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Physical Activity Intervention for Black Women With Asthma
NCT05726487
Active, positions filled
Conditions Asthma
Phase NA
Enrollment 224
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Physical inactivity is associated with poor asthma control and quality of life, and greater health care utilization. Rates of physical inactivity, asthma, and asthma mortality among Black women are higher than those of their White counterparts. Our formative work identified barriers to PA among Black women with asthma including a lack of social support, self-efficacy, unsafe neighborhood and fear related to experiences with life-threatening asthma exacerbations. Given the unique barriers to PA and high rates of physical inactivity that are associated with poor asthma outcomes in Black women, there is an urgent need to optimize PA interventions for this population. The proposed study uses our theory-driven intervention (ACTION: A lifestyle physiCal acTivity Intervention for minOrity womeN with asthma) to deliver a 24-week lifestyle physical activity intervention designed for and by urban Black women with asthma. Participants will be recruited through two urban health care systems that care for a diverse urban Black populations. Participants will be randomized to one of two groups: 1) ACTION intervention (group sessions, physical activity self-monitoring and text-based support for goal-setting), or 2) education control (an individual asthma education session and text messages related to asthma education). Participants will be followed for an additional 24-weeks after the intervention to assess for the maintenance of intervention effects on asthma health outcomes. We are proposing an efficacy study that focuses on asthma outcomes (Aim 1A/B), explores behavioral mechanisms of the intervention (Aim 2) and assesses factors that influence its reach and implementation potential (Aim 3). This trial will provide the first ever evidence of the efficacy of a lifestyle physical activity intervention among urban Black women with asthma, a population that is understudied yet plagued by low levels of PA and poor health outcomes. Our study has high potential to advance clinical treatment of asthma, and further the mechanistic understanding of physical activity interventions in minority populations living in low-resourced urban environments.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Triple

Interventions / Regimen

  • Behavioral: ACTION Intervention — Participants in the ACTION Intervention arm of the study will have group sessions, physical activity self-monitoring, text-based support for goal setting. Following this intervention participants will be followed for an additional 24-weeks to assess for the maintenance of intervention effects on asthma health outcomes.
  • Other: Education Control — Participants in the Education Control arm of the study will receive and individual asthma education session and text messages related to asthma education. Following this intervention participants will be followed for an additional 24-weeks to assess for the maintenance of intervention effects on asthma health outcomes.

Primary Outcomes

  • Asthma Control Questionnaire (24-weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2023-05-04
Completion: 2026-12-30
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 224 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Chicago
Collaborators: University of Illinois at Chicago, University of Texas at Austin
Principal Investigators:
  • Sharmilee Nyenhuis, MD (PRINCIPAL_INVESTIGATOR) - University of Chicago
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Behavioral: ACTION Intervention — Participants in the ACTION Intervention arm of the study will have group sessions, physical activity self-monitoring, text-based support for goal setting. Following this intervention participants will be followed for an additional 24-weeks to assess for the maintenance of intervention effects on asthma health outcomes.
  • Other: Education Control — Participants in the Education Control arm of the study will receive and individual asthma education session and text messages related to asthma education. Following this intervention participants will be followed for an additional 24-weeks to assess for the maintenance of intervention effects on asthma health outcomes.
Study Locations (2 sites)
University of Illinois Chicago, Chicago, Illinois 60607 United States
University of Chicago, Chicago, Illinois 60637 United States
Eligibility Criteria
Inclusion Criteria: * Self-identify as female and Black or African-American * Age \>/= 18 * Physician-diagnosed persistent asthma that is sub-optimally controlled based on Asthma Control Test (ACT \< 20) OR history in the past year of an asthma exacerbation (a need for systemic corticosteroids or hospital admission or emergency treatment for worsening asthma) * Willing to enroll and provide written-informed consent * Willing to be randomly assigned to treatment or control group * Low- active: engages in less than 150 minutes per week of moderate-to- vigorous physical activity * Has a smartphone and texts every day or almost everyday Exclusion Criteria: * Plans to relocate outside of the Chicagoland area during the study period * Unable to ambulate without the use of a wheelchair or scooter * Diagnosis of COPD (emphysema or chronic bronchitis) suggested by patient report of doctor diagnosis or smoking history (≥ 20 pack years) * Current tobacco smoker * A contraindication to exercise as indicated by the Physical Activity Readiness Questionnaire unless written permission by a health care provider * Significant medical (e.g., unstable heart disease, uncontrolled high blood pressure, active cancer treatment in past 1 year, end-stage organ failure) or psychiatric (e.g., active bipolar disorder, psychosis) comorbidities * Participation in another physical activity or asthma research program * Asthma exacerbation, defined by an urgent care visit for asthma in the last 4 weeks, or need for acute course of systemic corticosteroids for asthma in the last 4 weeks * Family/household member of another study participant or staff member * Inability to speak, read or understand English * Investigator discretion for safety or protocol adherence reasons * Unable or unwilling to provide complete accelerometry data at the baseline assessment after two opportunities to wear the monitor
Telehealth-Enhanced Asthma Care for Home After the Emergency Room
NCT05844891
Recruiting
Conditions Asthma in Children
Phase NA
Enrollment 430
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

The investigators propose a randomized controlled trial of Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER) vs. enhanced care (EC). TEACH-ER includes: 1) brief, pictorial, and health literacy-informed asthma education in the ED, with color- and shape-coded labels provided for home asthma medications; 2) virtual primary care follow-up within 1 week of discharge using in-home telemedicine (Zoom) when possible, featuring provider prompts for guideline-based preventive therapy and home delivery of prescribed medications with pictorial action plans; 3) two additional in-home virtual visits to reinforce teaching, review treatment plans, label medications, and support effective management practices. The investigators will enroll 430 children (ages 3-12 yrs) from the two dedicated pediatric EDs in our region, and follow all participants for a 12-month period. The investigators will call caregivers to complete blinded follow-up telephone surveys at 3, 6, 9, and 12 months after discharge. The investigators will assess the effectiveness of TEACH-ER in reducing the need for additional asthma-related ED visits or hospitalizations in the 1-months after enrollment. Additional outcomes of interest include asthma symptoms, medication adherence, absenteeism from work and school, quality of life, and the delivery of care consistent with national asthma care guidelines.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Health Services Research Masking/blinding: Single

Interventions / Regimen

  • Behavioral: Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER) — TEACH-ER aims to provide primary care management and educational support for families managing childhood asthma throughout the transition from emergency department to home, and includes several core components: 1) brief, pictorial, and health literacy-informed asthma education in the ED, with color- and shape-coded labels provided for home asthma medications; 2) virtual primary care follow-up within 1 week of discharge using in-home telemedicine (when possible), featuring provider prompts for guideline-based preventive therapy and home delivery of prescribed medications with pictorial action plans; 3) two additional in-home virtual visits to reinforce teaching, review treatment plans, label medications, and support effective management practices. Virtual visits will be completed using the Zoom platform on smartphones or other compatible devices. We anticipate that all three telehealth visits (1 provider visit, 2 educator visits) will be completed within 2 months of enrollment.
  • Behavioral: Enhanced Care (EC) — Similar to children in the TEACH-ER group, participants in the EC group will receive a symptom assessment using NHLBI guidelines, a recommendation for appropriate preventive medications, and asthma education materials given at the time of the ED visit. After baseline and randomization, we will send the child's PCP a symptom report with guideline-based recommendations for preventive care and recommend a follow-up visit with the PCP. We will also give all providers a summary of the current national guidelines. We will provide systematic feedback to the family and child's PCP at intervals that parallel the TEACH-ER group's telemedicine assessments. This feedback will include prompting caregivers to schedule a recommended follow-up appointment with the PCP, and encouraging providers to adhere to the NHLBI guidelines. While participants will not be blinded to their group allocation, they will be told that they are randomly assigned to two different ways of approaching asthma management.

Primary Outcomes

  • Number of asthma-related hospitalizations and emergency department visits after discharge (12 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-04-01
Completion: 2028-06-30
Eligibility
Age: 3 Years
Sex: ALL
Volunteers: false
Enrollment: 430 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Rochester
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Behavioral: Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER) — TEACH-ER aims to provide primary care management and educational support for families managing childhood asthma throughout the transition from emergency department to home, and includes several core components: 1) brief, pictorial, and health literacy-informed asthma education in the ED, with color- and shape-coded labels provided for home asthma medications; 2) virtual primary care follow-up within 1 week of discharge using in-home telemedicine (when possible), featuring provider prompts for guideline-based preventive therapy and home delivery of prescribed medications with pictorial action plans; 3) two additional in-home virtual visits to reinforce teaching, review treatment plans, label medications, and support effective management practices. Virtual visits will be completed using the Zoom platform on smartphones or other compatible devices. We anticipate that all three telehealth visits (1 provider visit, 2 educator visits) will be completed within 2 months of enrollment.
  • Behavioral: Enhanced Care (EC) — Similar to children in the TEACH-ER group, participants in the EC group will receive a symptom assessment using NHLBI guidelines, a recommendation for appropriate preventive medications, and asthma education materials given at the time of the ED visit. After baseline and randomization, we will send the child's PCP a symptom report with guideline-based recommendations for preventive care and recommend a follow-up visit with the PCP. We will also give all providers a summary of the current national guidelines. We will provide systematic feedback to the family and child's PCP at intervals that parallel the TEACH-ER group's telemedicine assessments. This feedback will include prompting caregivers to schedule a recommended follow-up appointment with the PCP, and encouraging providers to adhere to the NHLBI guidelines. While participants will not be blinded to their group allocation, they will be told that they are randomly assigned to two different ways of approaching asthma management.
Study Locations (1 sites)
University of Rochester Medical Center, Rochester, New York 14642 United States
Eligibility Criteria
Inclusion Criteria (all criteria must be met): * Physician diagnosis of asthma, based on review of medical records and/or caregiver report. * Current emergency visit for an acute asthma exacerbation, requiring treatment with rescue medication. * Persistent asthma or poor asthma control for which a daily controller medication is recommended by NHLBI guidelines, defined as any 1 of the following: 1. \>2 days/wk with asthma symptoms in the past month, 2. \>2 days/wk with rescue medication use in the past month, 3. \>2 days/month with nighttime symptoms in the past month (vs. 1-2 nights per month if 3-4 years old), or 4. ≥1 other episode of asthma during the past year that required systemic corticosteroids (vs. during the past 6 months if 3-4 years old). * Child age between ≥3 and ≤12 years. * Child and caregiver live in the greater Rochester, NY metropolitan area (Monroe, Wayne, Ontario, Livingston, Genesee, and Orleans Counties) * Emergency severity index triage scores of 2-5 (total range 1-5; scores of 1 indicate the highest acuity and likelihood of hospitalization). Exclusion Criteria: * An inability to speak and understand English. Parents (and children) with low literacy / health-literacy skills will be eligible, as survey instruments will be administered verbally and educational materials will be designed for low-literacy populations. * No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible location). If a subject does not have access to an appropriate device for Zoom visits at home, we will provide a device with required data plan. * Other significant medical conditions, including cystic fibrosis, congenital heart disease, or other chronic lung disease, that could interfere with the assessment of asthma-related measures. * Children in foster care or other situations in which consent cannot be obtained from a legal guardian.
The Rainbow Study - the Effect of Feedback on Asthmatic Symptom Perception
NCT06702735
Recruiting
Conditions Asthma in Children, Exercise Induced Ast...
Phase NA
Enrollment 39
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Asthma is a common childhood disease that is characterized by chronic airway inflammation and episodic expiratory airflow obstruction. Asthma symptoms can impair participation in play and sports and have a negative impact on quality of life. It can be challenging for children to adequately feel and report their symptoms. Some children experience more symptoms than expected based on lung function during these symptoms, whereas others experience less symptoms than expected. This is also called 'symptom perception'. A tool was developed to visualize symptoms, lung function and accessory symptom perception: The Rainbow tool. The aim of this study was to identify asthmatic children with a poor perception and investigate if their symptom perception could be improved by regular lung function measurements and personal feedback based on the Rainbow Tool. Hypothesis: Measuring lung function en symptoms and provide personal feedback on perception based on the Rainbow tool has a positive effect on perception of asthma-related symptoms in asthmatic children.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Diagnostic Masking/blinding: None

Interventions / Regimen

  • Behavioral: Rainbow tool — The Rainbow tool visualizes perception based on lung function measurements and VAS scores.
  • Behavioral: Feedback — Feedback sessions with health care professional based on the Rainbow tool.

Primary Outcomes

  • Perception score (Two week run-in versus last week of intervention)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-10-16
Completion: 2025-05-01
Eligibility
Age: 7 Years
Sex: ALL
Volunteers: false
Enrollment: 39 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Medisch Spectrum Twente
Principal Investigators:
  • Vera Hengeveld, MD (PRINCIPAL_INVESTIGATOR) - Medisch Spectrum Twente
Contact Information
Study Contact:
Vera Hengeveld, MD
+31534872310
vera.hengeveld@mst.nl
Mattienne van der Kamp, MSc, PhD
+31534872310
m.vanderkamp@mst.nl
Interventions
  • Behavioral: Rainbow tool — The Rainbow tool visualizes perception based on lung function measurements and VAS scores.
  • Behavioral: Feedback — Feedback sessions with health care professional based on the Rainbow tool.
Study Locations (1 sites)
Medisch Spectrum Twente, Enschede, Overijssel 7512 KZ Netherlands
Eligibility Criteria
Inclusion Criteria: Selection phase: * Pediatrician diagnosed asthma * Health care professional thinks perception might be poor * Age 7 until 15 years old * Adequate understanding of Dutch language Intervention phase: * Adequate number of lung function measurements + VAS scores during selection phase, defined as: * At least 4 measurements after exercise or when experiencing symptoms and * At least 2 standard measurements * Poor perception during selection phase, defined as: * At least 1 measurement in red zone on Perception Rainbow and/or * At least 2 measurements in orange zone on Perception Rainbow and/or * Average of all measurements after exercise or when experiencing symptoms in yellow zone (or orange/red)and/or * Average of all measurements in yellow zone (or orange/red) Exclusion Criteria: * Severe comorbidity (for example psychomotor retardation or severe cardiopulmonary conditions) * Not able to fill in VAS score (for example due to blindness) * Not able to perform technically correct spirometry manoeuvres * Medication change in past 2 weeks * Exacerbation which required oral prednisone in the past 6 weeks * Exacerbation at the moment of inclusion * No device (computer, tablet or smartphone) with internet connection available at home
Association Between Genetic Polymorphisms and Type 2 Asthma in Children
NCT06840717
Recruiting
Conditions Asthma in Children, Genetic Disease, Inf...
Phase Not Applicable
Enrollment 300
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

To further understand the role of gene single nucleotide polymorphism (SNP) in the occurrence of type 2 inflammation-related asthma in children by analyzing the gene single nucleotide polymorphism (SNP), lung function and type 2 inflammation indicators of children diagnosed with asthma in outpatient and inpatient. To provide a theoretical basis for the study of personalized treatment and prevention strategies for asthma.

Design

Study type: Observational Observational model: Case Control Time perspective: Prospective

Primary Outcomes

  • type 2 inflammation indicators (Outpatient visits for the first time)
  • pulmonary function indicators (Outpatient visits for the first time)
  • single nucleotide polymorphism (Outpatient visits for the first time)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2024-01-30
Completion: 2025-12-30
Eligibility
Age: 3 Years
Sex: ALL
Volunteers: true
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Guangzhou Institute of Respiratory Disease
Contact Information
Study Contact:
Lihong Sun, M.D.
13719240285
sunlihong9797@126.com
Lanying Cheng
15918742726
chenglanyingmed@163.com
Interventions
N/A
Study Locations (1 sites)
Guangzhou institute of respiratory disease, Guangzhou, Guangdong 510120 China
Eligibility Criteria
Inclusion Criteria: 1. All children with asthma diagnosis accord with the GINA in 2023 edition; 2. Other diseases that could cause wheezing and cough were excluded, such as acute laryngitis, diphtheria, congenital airway abnormalities, and tracheal foreign bodies; 3. In front of the hospital 2 weeks without antibiotics, systemic hormone medication history; 4. There were no other complications, such as congenital heart disease, pneumonia, gastroesophageal reflux disease, muscle dysplasia, etc. Exclusion Criteria: 1. Children who had taken immunosuppressants, antibiotics and other drugs for a long time before admission; 2. Children with primary immunodeficiency disease; 3. The children and their families failed to cooperate or refused the experimental observation.
A Study to Investigate the Efficacy and Safety of GSK5784283 Compared With Placebo in Participants With Uncontrolled Asthma (PERSIST ASTHMA-1)
NCT07780643
Not yet recruiting
Conditions Asthma
Phase PHASE3
Enrollment 514
Locations 0 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The study aims to demonstrate the superiority of GSK5784283 compared to placebo in reducing the annualized rate of clinically meaningful asthma exacerbations.

Design

Study type: Interventional Phases: Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Drug: GSK5784283 — GSK5784283 will be administered.
  • Drug: Placebo — Placebo will be administered.
  • Drug: Standard of care — Standard of care will be administered.

Primary Outcomes

  • Annualized rate of clinically significant asthma exacerbations (Up to Week 52)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Not yet recruiting
Start Date: 2026-08-31
Completion: 2029-10-11
Eligibility
Age: 12 Years
Sex: ALL
Volunteers: false
Enrollment: 514 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: GlaxoSmithKline
Principal Investigators:
  • GSK Clinical Trials (STUDY_DIRECTOR) - GlaxoSmithKline
Contact Information
Study Contact:
US GSK Clinical Trials Call Center
877-379-3718
GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center
+44 (0) 20 89904466
GSKClinicalSupportHD@gsk.com
Interventions
  • Drug: GSK5784283 — GSK5784283 will be administered.
  • Drug: Placebo — Placebo will be administered.
  • Drug: Standard of care — Standard of care will be administered.
Eligibility Criteria
Inclusion Criteria: * Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in Informed consent form (ICF). For participants aged 12 to 17 years, signed assent must be obtained from the participant in addition to signed consent from their Legally acceptable representative (LAR). * Participants aged 12 to 80 years at the time of signing the informed consent. * Male or eligible female participants: * Female participants: * A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: i. Is a Participant of non-childbearing potential (PONCBP) or ii. Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\<) 1 percent (%), 28 days prior to the first dose of the study drug, and during the study intervention period and follow-up period for at least 60 weeks after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention. * A POCBP must have a negative serum pregnancy test at screening and a highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before each dose of study intervention. * If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. * Contraceptive use by women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical trials. * A documented physician diagnosis of asthma for at least 12 months prior to Visit 1, according to the Global Initiative for Asthma (GINA) 2026 guidelines. * Evidence of variable airflow obstruction consistent with asthma. * Documented history of asthma exacerbation within 12 months prior to Visit 1. * A well-documented requirement for regular treatment with medium or high dose Inhaled corticosteroid (ICS) for at least 3 months prior to screening with or without maintenance oral corticosteroids (OCS). * At least 1 additional maintenance asthma controller medication is required according to standard practice of care (e.g., Long-acting beta-2 agonist \[LABA\], Leukotriene receptor antagonists \[LTRA\], theophylline, Long-acting muscarinic agonists \[LAMA\], chromones, etc.). Use of additional asthma controller medications must be documented for at least 3 months prior to screening. * Uncontrolled asthma based on ACQ-5 score. Exclusion Criteria: * Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of participant safety or study results. * History of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix). * Myocardial infarction, unstable angina or stroke within 6 months of screening, unstable arrhythmia. * New York Heart Association (NYHA) class III or IV heart failure. * Other significant medical conditions that could impact participants' safety or study outcomes. * History of an unresolved clinically significant infection within 30 days prior to Visit 1. * A known immunodeficiency, other than that explained by the use of corticosteroids taken as therapy for asthma. * Receipt of any marketed or investigational biologic agent or investigational non-biologic agent, prior to Visit 1. * Use of systemic immunosuppressive medication within 3 months prior to Visit 1 (other than systemic corticosteroid burst or stable maintenance OCS for treatment of asthma). * Current smokers (tobacco and/or marijuana), current users of vaping products/electronic-cigarettes or participants with a smoking history \>=10 pack-years.
Study of the Impact of Exposure to Outdoor and Indoor Pollutants in Patients With Asthma
NCT05525169
Recruiting
Conditions Asthma
Phase Not Applicable
Enrollment 30
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The project is to measure exposure to outdoor and indoor air pollutants in asthma patients in order to show a possible association between variation in pollutant exposure and the occurrence of exacerbations in these patients

Design

Study type: Observational Observational model: Other Time perspective: Prospective

Primary Outcomes

  • Asthma exacerbations (36 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2022-11-15
Completion: 2026-11-15
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Nantes University Hospital
Principal Investigators:
  • François-Xavier Blanc, PU-PH (PRINCIPAL_INVESTIGATOR) - Nantes University Hospital
Contact Information
Study Contact:
François-Xavier Blanc, PU-PH
02 40 16 53 33
xavier.blanc@chu-nantes.fr
Megguy Bernard
megguy.bernard@chu-nantes.fr
Interventions
N/A
Study Locations (1 sites)
CHU de Nantes, Nantes, 44093 France
Eligibility Criteria
Inclusion Criteria: * Patient over 18 years of age, * Patient with a confirmed diagnosis of asthma for at least 12 months as defined by the investigator, * Patient with at least 4 asthma exacerbations in the last year * Patient sleeping at least 6 nights per week in the same home Exclusion Criteria: * Patient who is an active smoker or living with an active smoker, * Patient with a diagnosis of COPD, ABPA or associated pulmonary fibrosis, * Patient with an asthma exacerbation within 15 days prior to the inclusion visit, * Patient with known occupational exposure, * Patient living in a dwelling that does not allow the installation of sensors (inability to connect the sensor to the power supply, no location for the outdoor sensor...) * Patient who plans to move in the next 6 months, * Patient with a life expectancy of less than 6 months, * Patient who has someone living in their household also included in EXAP, * Patient who lives in an apartment and does not have a balcony or space for the outdoor sensor, * Pregnant or breastfeeding women,
Mechanistic Insights From Bronchoscopy Airway Samples
NCT06105710
Recruiting
Conditions Asthma
Phase Not Applicable
Enrollment 24
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study is to examine the mechanisms of asthma. The investigators are comparing the cells of individuals with and without asthma and looking at the roles various parts of the cell play in the production and secretion of mucus.

Design

Study type: Observational Observational model: Case Control Time perspective: Cross Sectional

Primary Outcomes

  • Quantitate mean gene expression of TSPAN8 in goblet cells from the airways of human asthma and health and report the mean for asthma and health (main outcome 1) and for both goblet cells and non-goblet cells in asthma. (Between 1-12 weeks)
  • Quantitate KRT8 in airway cells from human asthma vs health and report the mean level in the transitional secretory cell subset for both asthma and health. (Between 1-12 weeks)
  • Quantitate expression of miR-141/200 family members report mean expression for the transitional secretory cell population in human asthma vs health using methods similar to those in Outcomes 1 and 2. (Between 1-12 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2024-07-01
Completion: 2028-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 24 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of California, San Francisco
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigators:
  • Nirav Bhakta, MD, PhD (PRINCIPAL_INVESTIGATOR) - University of California, San Francisco
  • Prescott Woodruff, MD, MPH (PRINCIPAL_INVESTIGATOR) - University of California, San Francisco
Contact Information
Study Contact:
Christine P Nguyen, BS
628-233-1233
christine.nguyen@ucsf.edu
Interventions
N/A
Study Locations (1 sites)
University of California, San Francisco, San Francisco, California 94143 United States
Eligibility Criteria
Inclusion Criteria: * Healthy Controls 1. Male and female subjects between the ages of 18 and 70 years 2. Ability to provide written informed consent and ability to comply with the requirements of the study 3. No hyperreactivity to methacholine (PC20 FEV1 Methacholine \>16 mg/mL) 4. No history of allergic rhinitis/seasonal allergies * Asthmatics 1. Male and female subjects between the ages of 18 and 70 years 2. Ability to provide written informed consent and ability to comply with the requirements of the study 3. History of asthma 4. No use of oral or inhaled corticosteroids for the treatment of asthma during the past 6 weeks 5. Hyperreactivity to methacholine (PC20 FEV1 Methacholine \< 8 mg/ml) Exclusion Criteria: The same exclusion criteria will apply to both Sub-studies. 1. Current smokers, defined by (a) \>5 cigarettes smoked in past 12 months, and (b) ≤ 8 weeks since last time smoking; or former smokers who have a total smoking history * 10 pack-years 2. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study 3. Subjects with a history of lung disease other than asthma 4. Subjects with a history of prior esophageal hernia surgery 5. Subjects with a history of a medical disease, which in the opinion of the Investigator may put the subject at extra risk from study-related procedures or because the disease may influence the results of the study 6. Current participation in an investigational drug trial Prohibited Medications and Treatments The following medications are prohibited during the study and must be discontinued prior to enrollment for the amount of time specified below. 1. Astemizole: 12 weeks 2. Steroids (oral, inhaled or nasal): 6 weeks 3. Nedocromil sodium, sodium cromoglycate: 4 weeks 4. Long-acting methylxantines: 2 days 5. Short-acting methylxantines: 12 hours 6. Montelukast: 7 days 7. Zafirlukast: 7 days 8. Salmeterol: 2 days 9. Omalizumab: 6 months Medications to be withheld prior to bronchoscopy: Aspirin or Non- steroidal anti-inflammatory agents (NSAIDs) for 2 days Medications to be withheld before each clinic visit: Short-acting bronchodilators (e.g. Albuterol) for 6 hours; Short-acting anti- cholinergics (e.g. Atrovent, Combivent) for 8 hours; and antihistamines (e.g. Benadryl, Claritin) for 3 days.
Upper Airway Microbial Development During the First Year of Life
NCT01978288
Active, positions filled
Conditions Asthma
Phase Not Applicable
Enrollment 180
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

This study tests the hypothesis that an increase in pathogenic bacteria within the infant airway leads to increased airway inflammation, decreased airway function and ultimately airway obstruction throughout the first one to two years of life.

Design

Study type: Observational Observational model: Case Only Time perspective: Prospective

Primary Outcomes

  • Change in airway bacteria diversity during first 12 months of life. (Birth and 12 months (+/- 2 months))
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2014-01
Completion: 2026-12-31
Eligibility
Age: 1 Minute
Sex: ALL
Volunteers: false
Enrollment: 180 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Indiana University
Collaborators: National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigators:
  • Kirsten Kloepfer, MD (PRINCIPAL_INVESTIGATOR) - Indiana University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (1 sites)
Riley Hospital for Children at Indiana University Health, Indianapolis, Indiana 46202 United States
Eligibility Criteria
Inclusion Criteria: 1. Moms age 14 and older (will sign Informed Consent Statement (ICS), not an assent) 2. Mother of child enrolled must have a physician diagnosis of asthma or being treated for asthma (for 140 subjects; 40 subjects will be recruited from mothers and fathers without atopy - asthma, eczema, seasonal allergies) 3. Child must be enrolled during first week of life 4. Signed informed consent from parent(s) or legal guardian(s) Exclusion Criteria: 1. Child has a history of wheezing or underlying lung disease 2. Respiratory complications at birth (airway support higher then nasal cannula) 3. Born earlier then 37 weeks gestation 4. Congenital heart defects (not including Patent Ductus Arteriosus (PDA), hemodynamically insignificant Ventricular Septal Defect (VSD) or Atrial Septal Defect (ASD) 5. Underlying neuromuscular disease 6. Severe upper airway obstruction, sleep apnea, tracheomalacia, or laryngomalacia 7. Hydrocephalus 8. History of seizures 9. History of arrhythmia and baseline oxygenation level \<90% on room air 10. Infant is non-viable 11. Severe gastroesophageal reflux 12. Prior chest surgery or structural abnormalities of the lungs or chest wall 13. Has a history of adverse reaction to chloral hydrate 14. Ward of the state 15. Any physical finding(s) that would compromise the safety of the subject or the quality of the study data as determined by the site investigator
Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses.
NCT04898283
Recruiting
Conditions Rhinitis, Allergic, Rhinoconjunctivitis,...
Phase PHASE3
Enrollment 180
Locations 27 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Immunotherapy in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitized to cupressaceae and grasses.

Design

Study type: Interventional Phases: Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Biological: 10,000 MG01 +10,000 T521 — Purified and polymerized with glutaraldehyde allergen extract, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and cupressaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
  • Biological: 30,000 MG01 +10,000 T521 — Purified allergen extract polymerized with glutaraldehyde, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and cupressaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections.
  • Other: Placebo subcutaneous — The same solution and presentation as the active treatment, but without active ingredients

Primary Outcomes

  • RCSMS: Combined Symptoms and Medication Score of rhinitis. Combined symptom and medication score in rhinitis/rhinoconjunctivitis (RCSMS) (18 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2021-05-31
Completion: 2026-10
Eligibility
Age: 12 Years
Sex: ALL
Volunteers: false
Enrollment: 180 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Inmunotek S.L.
Principal Investigators:
  • Pedro Ojeda, MD (STUDY_DIRECTOR) - Clínica privada Dres Ojeda
Contact Information
Study Contact:
Miguel Casanovas, MD PhD
+34 912908942
mcasanovas@inmunotek.com
Raquel Caballero
+34 607600638
rcaballero@inmunotek.com
Interventions
  • Biological: 10,000 MG01 +10,000 T521 — Purified and polymerized with glutaraldehyde allergen extract, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and cupressaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
  • Biological: 30,000 MG01 +10,000 T521 — Purified allergen extract polymerized with glutaraldehyde, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and cupressaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections.
  • Other: Placebo subcutaneous — The same solution and presentation as the active treatment, but without active ingredients
Study Locations (27 sites)
Hospital Recoletas Felipe Ii, Valladolid, Castille and León 47003 Spain
Cedt de Tarancón, Tarancón, Cuenca 16400 Spain
Hospital Universitario Principe de Asturias, Alcalá de Henares, Madrid 28806 Spain
Hospital U. Fundación Alcorcón, Alcorcón, Madrid 28922 Spain
Hospital Cruz Roja Madrid, Madrid, Madrid 28003 Spain
Clínica Privada Dres Ojeda, Madrid, Madrid 28006 Spain
Hospital Universitario Puerta de Hierro, Majadahonda, Madrid 28222 Spain
Clínica Privada Murcia, Murcia, Murcia 30006 Spain
Hospital Nuestra Señora de Sonsoles, Ávila, 05071 Spain
Fundación Hospital Sant Pere Claver, Barcelona, 08004 Spain
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent. 2. Aged between 12 and 65, both genders 3. Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis according to ARIA classification, with or without moderate intermittent or persistent asthma,according to GEMA 5.0, due to grass and cupressaceae pollen. 4. Subjects with a positive skin prick-test (wheal size \>5 mm diameter) to a standardized mixed extract of grass pollen (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne) or to one of the molecular components of the mixture and to a cupressaceae extract. In addition, the largest diameter of the papules must be greater than or equal to that of the histamine. 5. Specific IgE \> 3,5 KU/L , against grass (preferably Phleum pratense) and cupressaceae pollen (InmunoCAP® o Immulite). 6. Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial. 7. Women of childbearing potential participating in the trial, should commit to using an appropriate method of contraception. Medically acceptable methods of contraception are intrauterine devices placed at least 3 months in advance, surgical sterilization (for example, tubal ligation), barrier methods, or the use of oral contraceptives. 8. Subjects capable of complying with the dosing regimen. 9. Subjects who own a smartphone for symptom registration and medication. 10. Subjects with a negative prick test to coestational pollens. In the case specific IgE is available, the result should be \<3,5 kU/L and without relevant symptomatology 11. Subjects with a negative prick test to other aeroallergens (dust mites, epitheliums and fungus). In the case specific IgE is available, the result should be \<3,5 kU/L and without relevant symptomatology. Exclusion Criteria: 1. Subjects with positive prick test to other aeroallergens except for sensitisation to epithelia with occasional exposure and symptoms. 2. Subjects with positive prick test to other aeroallergens except for sensitisation to pollen noncoseasonal with cupressus or grasses. 3. Subjects who have received prior immunotherapy in the preceding 5 years for any of the allergens tested or a cross-reactive allergen or are currently receiving immunotherapy with any allergen. 4. Subjects in which immunotherapy may be subject to an absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee. 5. Subjects with severe or uncontrolled intermittent or persistent asthma, with an FEV1 \<70% with respect to the reference value despite adequate pharmacological treatment at the time of inclusion in the trial. Likewise, subjects with intermittent or persistent rhinitis / rhinoconjunctivitis with severe symptoms in which the suspension of oral or systemic antihistamine treatment is contraindicated. 6. Subjects who have previously had a severe secondary reaction during the prick test diagnostic skin test. 7. Subjects treated with beta-blockers. 8. Clinically unstable subjects at the time of inclusion in the trial (acute asthmatic exacerbation, respiratory infection, febrile process, acute urticaria, etc.). 9. Subjects with active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin tests will be performed, or a history of hereditary angioedema. 10. Subjects who have any pathology in which adrenaline administration is contraindicated (hyperthyroidism, HTN, heart disease, etc.). 11. Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but potentially serious and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations, multioperated patients, kidney disease,). 12. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies. 13. Subject whose condition prevents from offering cooperation and/ or who has severe psychiatric disorders. 14. Subjects with a known allergy to components of the investigational medicinal product other than the allergen. 15. Subjects with lower respiratory diseases other than asthma such as emphysema or bronchiectasis. 16. Subjects who are direct relatives of the researchers. 17. Pregnant or lactating women.
SMART Implementation-Effectiveness Trial 1
NCT07137923
Recruiting
Conditions Asthma in Children
Phase NA
Enrollment 18
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

While single maintenance and reliever therapy (SMART) has been the preferred management strategy for Step 3 and 4 (moderate/severe) asthma management since the 2020 NIH asthma guideline updates, adoption of SMART has not been rigorously assessed. This study will test electronic medical record clinical decision support and education implementation strategies (CDS+) to increase adoption of SMART in pediatric primary care. This is the first of two related records.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Health Services Research Masking/blinding: Single

Interventions / Regimen

  • Behavioral: Clinical decision support + education (CDS+) — Intervention clinic providers will experience nudges in the electronic medical record to encourage prescribing SMART where clinically-appropriate and intervention clinic providers, families/patients, and nurses will receive education (collectively CDS+).
  • Other: Control — Clinics in Arm 2 will not be exposed to the interventions.

Primary Outcomes

  • Change in the Rate of Visit-Level SMART Adoption (Assessment of rates from two study intervals: Interval 0 (baseline; 11 months), Interval 1 (CDS+; 11 months). There will be a one month ramp up period at the start of each study interval (ramp up period data will not be included in analyses).)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-09-03
Completion: 2028-02-29
Eligibility
Age: 5 Years
Sex: ALL
Volunteers: false
Enrollment: 18 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Children's Hospital of Philadelphia
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Contact Information
Study Contact:
Chén Kenyon, MD, MSHP
267-426-6339
kenyonc@chop.edu
Interventions
  • Behavioral: Clinical decision support + education (CDS+) — Intervention clinic providers will experience nudges in the electronic medical record to encourage prescribing SMART where clinically-appropriate and intervention clinic providers, families/patients, and nurses will receive education (collectively CDS+).
  • Other: Control — Clinics in Arm 2 will not be exposed to the interventions.
Study Locations (1 sites)
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104 United States
Eligibility Criteria
Clinic Inclusion Criteria: * The clinic is a pediatric primary care clinic that is part of the Children's Hospital of Philadelphia (CHOP) Pediatric Research Consortium (PeRC). * The clinic agrees to participate in SMART \& SIMPLE study. Clinic Exclusion Criteria: \- The clinic is not willing to participate in SMART \& SIMPLE study interventions. Patient Inclusion Criteria: * Ages 5-18 years; * Has clinic visit at participating practice during study interval (sick, well, or follow-up) * Prescribed at least one prescription for an inhaled corticosteroid (ICS) or ICS-long-acting beta agonist (ICS-LABA) for maintenance asthma therapy in the past year; * Evidence of uncontrolled asthma as determined by: (1) uncontrolled Asthma Control Tool score in the past 6 months OR (2) two or more systemic corticosteroids prescribed for an asthma exacerbation in the past 12 months (one occurring in the past 6 months) Patient Exclusion Criteria: \- Transferred clinics or left the CHOP Pediatric Care Network.
Asthma Link Effectiveness Trial
NCT06388460
Recruiting
Conditions Childhood Asthma
Phase NA
Enrollment 350
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

The goal of this cluster Randomized Control Trial is to determine the effectiveness of Asthma Link, a school supervised asthma therapy program, compared with an educational asthma workbook, in improving asthma symptoms for children with poorly controlled asthma aged 5-14.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Health Services Research Masking/blinding: None

Interventions / Regimen

  • Other: Asthma Link — Providers enroll patients to receive school-supervised asthma therapy and an asthma educational workbook
  • Other: Enhanced Usual Care — Providers enroll patients to receive an asthma educational workbook

Primary Outcomes

  • Improving Asthma Symptoms (Baseline, 6 months, 12 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-04-04
Completion: 2028-04
Eligibility
Age: 5 Years
Sex: ALL
Volunteers: false
Enrollment: 350 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Massachusetts, Worcester
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigators:
  • Michelle Trivedi, MD (PRINCIPAL_INVESTIGATOR) - UMass Chan Medical School
Contact Information
Study Contact:
Michelle Trivedi, MD
7744418086
Michelle.Trivedi3@umassmed.edu
Michelle Spano, MA
17746966875
michelle.spano@umassmed.edu
Interventions
  • Other: Asthma Link — Providers enroll patients to receive school-supervised asthma therapy and an asthma educational workbook
  • Other: Enhanced Usual Care — Providers enroll patients to receive an asthma educational workbook
Study Locations (1 sites)
University of Massachusetts Chan Medical School, Worcester, Massachusetts 01655 United States
Eligibility Criteria
STUDY INCLUSION/EXCLUSION CRITERIA: Child Inclusion Criteria: * Meet the eligibility criteria for Asthma Link (as described below) * Enrolled in Asthma Link (if randomized to the Asthma Link Condition) * Able and willing to provide informed assent Child Exclusion Criteria: * Unable or unwilling to provide informed assent * Developmental delay that would prevent study participation. Parent Inclusion Criteria: * Parent/guardian to patient * 18 years or older * Able to understand and communicate in English or Spanish * Able and willing to provide informed consent. Child eligibility for children enrolled in Asthma Link: * children aged 5-14 years (enrolled in grade K-8) * prescribed daily inhaled corticosteroid (ICS) for asthma * Asthma Control Test (ACT) score ≤19 OR 1 or more of ANY of following in the past 1 year: course of oral steroids, hospitalization, Emergency Department visit, sick visit for asthma * parent/child report of poor ICS adherence on adherence checklist- i.e. child or parent says "Yes" when provider asks if they have difficulty remembering to take their medication or if they regularly take medication holidays or breaks * able and willing to assent * parental permission * English or Spanish speaking
Use of Biologics for Severe Asthma in Hong Kong
NCT06778746
Recruiting
Conditions Asthma
Phase Not Applicable
Enrollment 360
Locations 1 sites
Compensation paid available
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The landscape of biologics therapy used in Hong Kong is currently unknown. The purpose of this study is to conduct a retrospective analysis of the use of biologics treatment for severe asthma in Hong Kong. The study aims to assess the landscape of biologics usage, evaluate the characteristics and conditions of patients before and after receiving biologic therapy, and provide insights into the effectiveness and safety of these treatments in the local population.

Design

Study type: Observational Observational model: Case Only Time perspective: Retrospective

Interventions / Regimen

  • Other: no interventions — No interventions, this is an observational study

Primary Outcomes

  • To determine the prevalence and patterns of biologics utilization for severe asthma in Hong Kong. (12 months)
  • To evaluate exacerbation rates before and after the initiation of biologic treatment. (12 months)
  • To evaluate the asthma control before and after the initiation of biologic treatment. (12 months)
  • To evaluate the lung function before and after the initiation of biologic treatment. (12 months)
  • To explore whether physicians are following international guidelines for the prescription of biologics (baseline)
  • To identify any adverse events associated with biologic therapy in the study population (12 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2024-12-26
Completion: 2027-12-26
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 360 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Chinese University of Hong Kong
Principal Investigators:
  • Fanny WS Ko, MD (PRINCIPAL_INVESTIGATOR) - Chinese University of Hong Kong
Contact Information
Study Contact:
Fanny WS Ko, MD
852 35053133
fannyko@cuhk.edu.hk
David SC Hui, MD
852 35053133
dschui@cuhk.edu.hk
Interventions
  • Other: no interventions — No interventions, this is an observational study
Study Locations (1 sites)
Department of Medicine and Therapeutics, Prince of Wales Hospital, Shatin, NT, HK, Hong Kong, Hong Kong
Eligibility Criteria
Inclusion Criteria: * Patients aged 18 years or older. * Patients diagnosed with severe asthma per the Global Initiative for Asthma (GINA) guidelines. * Patients who have received biologic therapy for treatment of asthma (including those who received just one dose to allow assessment of the reason for withdrawal) Exclusion Criteria: \- Patients with respiratory diseases with other known significant respiratory diseases, including tuberculosis (TB)-destroyed lung parenchyma, history of lung resection and lung cancer
Nutrition for Asthmatics
NCT06151405
Recruiting
Conditions Asthma
Phase NA
Enrollment 15
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

Determine to what extent three distinct dietary approaches improve asthma control and lung function.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Crossover Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Other: DGA Diet — A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans (DGA) Including: * A variety of vegetables and fruits * Grains, at least half of which are whole grains * Fat-free or low-fat dairy * A variety of protein foods, including seafood, lean meats and poultry, eggs, legumes, nuts, and seeds * This healthy eating pattern also limits saturated fats and trans fats, added sugars, and sodium.
  • Other: MCT Diet — A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).
  • Other: KETO Diet — A fully provisioned isocaloric, isonitrogenous ketogenic study diet.

Primary Outcomes

  • Asthma Control (Baseline)
  • Asthma Control (After 7 days on Diet#1)
  • Asthma Control (After 7 days on Diet#2)
  • Asthma Control (After 7 days on Diet#3)
  • Lung Function (Baseline)
  • Lung Function (After 7 days on Diet#1)
  • Lung Function (After 7 days on Diet#2)
  • Lung Function (After 7 days on Diet#3)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-07-17
Completion: 2027-03-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 15 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Pennington Biomedical Research Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigators:
  • Jacob T Mey, PhD, RD (PRINCIPAL_INVESTIGATOR) - Pennington Biomedical Research Center
Contact Information
Study Contact:
Jacob T Mey, PhD, RD
225-763-2644
jacob.mey@pbrc.edu
John P Kirwan, PhD
225-763-2644
john.kirwan@pbrc.edu
Interventions
  • Other: DGA Diet — A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans (DGA) Including: * A variety of vegetables and fruits * Grains, at least half of which are whole grains * Fat-free or low-fat dairy * A variety of protein foods, including seafood, lean meats and poultry, eggs, legumes, nuts, and seeds * This healthy eating pattern also limits saturated fats and trans fats, added sugars, and sodium.
  • Other: MCT Diet — A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).
  • Other: KETO Diet — A fully provisioned isocaloric, isonitrogenous ketogenic study diet.
Study Locations (1 sites)
Pennington Biomedical Research Center, Baton Rouge, Louisiana 70808 United States
Eligibility Criteria
Inclusion Criteria: * Age: 18-65 years * BMI: 18.5 - 29.99 kg/m2 * asthma diagnosed by medical specialist (confirmed in medical history) * partly controlled or uncontrolled asthma by Asthma Control Test score ≤22 * owns a device compatible with ZEPHYRx platform * stable asthma medication use (no change in the past 2 months). Exclusion Criteria: * Diabetes or using diabetes medications that may lower blood glucose levels * point of care fasting blood glucose ≥126 mg/dl or triglycerides ≥400 mg/dl * current smoking or smoking history of greater than 10 pack-years * other significant respiratory or cardiac disease or the presence of clinically important comorbidities, e.g., COPD, renal failure, liver disease; uncontrolled hypertension defined as systolic blood pressure ≥160 mm/Hg, or diastolic blood pressure ≥100 mm/Hg * pregnant or nursing women * food preferences or allergies inconsistent with study diet capabilities * noncompliance with lead-in period requirements.
Physical Activity Promotion and Clinical Remission in Severe Asthma
NCT07735494
Recruiting
Conditions Severe Asthma
Phase NA
Enrollment 140
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study will investigate whether a structured physical activity promotion programme, delivered alongside standard treatment with tezepelumab, increases objectively measured physical activity and the proportion of adults with severe asthma achieving clinical remission compared with standard care alone. Although biologic therapies have improved asthma control for many people with severe asthma, many individuals remain physically inactive, experience reduced exercise tolerance, and continue to report symptoms that affect their quality of life. Physical inactivity may represent a modifiable factor that limits the achievement of optimal health outcomes. Adults with severe asthma who are starting tezepelumab as part of routine clinical care will be randomly assigned to receive either standard care alone or standard care plus a 12-week physical activity promotion programme. The programme includes an individual consultation, group behavioural support sessions, personalised goal setting, self-monitoring using a smartphone application, and strategies to help participants increase and maintain their physical activity levels. Participants will be followed for 12 months. The study will primarily assess change in objectively measured daily step count after 3 months. The primary clinical outcome will be the proportion of participants achieving clinical remission after 12 months. Additional outcomes include asthma disease stability, asthma exacerbations, objectively measured physical activity at 12 months and functional exercise capacity. The findings will help determine whether combining physical activity promotion with biologic therapy improves outcomes for adults with severe asthma and could inform future models of routine severe asthma care.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Behavioral: Physical activity promotion — A 12-week structured physical activity promotion programme delivered alongside standard care for severe asthma. The intervention comprises an individual behavioural consultation followed by six online group support sessions delivered every two weeks. It incorporates evidence-based behaviour change techniques, including personalised goal setting, action planning, self-monitoring using the Active10 smartphone application, feedback, problem solving, and relapse prevention, informed by the Capability, Opportunity, Motivation-Behaviour (COM-B) framework to support sustained increases in daily physical activity.
  • Drug: Tezepelumab — Tezepelumab administered according to the licensed prescribing information and routine clinical practice for the treatment of severe asthma. All participants receive tezepelumab as standard care throughout the study.

Primary Outcomes

  • Daily step count (Baseline to 3 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-07-31
Completion: 2029-12-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 140 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Leeds
Collaborators: Hull University Teaching Hospitals NHS Trust, Bradford Institute for Health Research, Mid Yorkshire Teaching NHS Trust, Sheffield Teaching Hospitals NHS Foundation Trust
Contact Information
Study Contact:
Oliver J Price, PhD
+44(0)113 343 2909
o.price1@leeds.ac.uk
Ian J Clifton, MD
i.clifton@nhs.net
Interventions
  • Behavioral: Physical activity promotion — A 12-week structured physical activity promotion programme delivered alongside standard care for severe asthma. The intervention comprises an individual behavioural consultation followed by six online group support sessions delivered every two weeks. It incorporates evidence-based behaviour change techniques, including personalised goal setting, action planning, self-monitoring using the Active10 smartphone application, feedback, problem solving, and relapse prevention, informed by the Capability, Opportunity, Motivation-Behaviour (COM-B) framework to support sustained increases in daily physical activity.
  • Drug: Tezepelumab — Tezepelumab administered according to the licensed prescribing information and routine clinical practice for the treatment of severe asthma. All participants receive tezepelumab as standard care throughout the study.
Study Locations (1 sites)
Leeds Teaching Hospitals NHS Trust, Leeds, LS9 7TF United Kingdom
Eligibility Criteria
Inclusion Criteria: * Adults aged 18-70 years. * Physician-diagnosed severe asthma. * Eligible for tezepelumab according to NICE TA880. * History of ≥3 asthma exacerbations requiring oral corticosteroids in the previous 12 months or receiving maintenance oral corticosteroid therapy. * Objective confirmation of asthma, including bronchodilator reversibility, bronchial hyperresponsiveness and/or variable airflow obstruction, as part of routine clinical assessment. * Decision to commence tezepelumab made by the treating multidisciplinary severe asthma team prior to study enrolment. * Able and willing to provide written informed consent. Exclusion Criteria: * Non-asthma respiratory disease that may confound study outcomes (e.g. obstructive sleep apnoea). * Pregnancy. * Significant non-asthma medical conditions likely to impair physical activity or functional exercise capacity (e.g. acute musculoskeletal injury). * Any condition that, in the opinion of the investigator, would make participation unsafe or compromise study completion.
Asthma Intervention With Residential Ventilation and Air Cleaner (AIRVAC) Study
NCT07196436
Recruiting
Conditions Asthma Control, Pulmonary Function, Qual...
Phase NA
Enrollment 80
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The primary goal of this study is to investigate the comparative long-term (i.e., 1-year) effectiveness of energy recovery ventilators (ERVs) and portable air cleaners (PACs) in reducing indoor air pollutants and mold levels and improving asthma-related health outcomes in inner-city children and adults with asthma in low-income households in the Dallas-Fort Worth (DFW) metropolitan area, TX. Secondary goals include: (1) examining associations among asthma outcomes, exposure to indoor air pollutants and mold, and housing-related factors, (2) conducting a cost-benefit analysis of ERV and PAC interventions for improving IAQ, mold control, and health outcomes, and (3) evaluating the utility of cost-effective methods and protocols for measuring IAQ and mold for indoor air pollution epidemiology studies and for providing practical information to patients and their physicians. Using a double-blind, placebo-controlled randomized controlled trial, 80 households will be assigned to receive active or placebo versions of ERVs or PACs. Environmental exposures and housing conditions will be monitored alongside comprehensive health assessments, including lung function tests and validated surveys on asthma control, quality of life, stress, and sleep quality.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Single

Interventions / Regimen

  • Device: Energy Recovery Ventilator — A mechanical ventilation system that exchanges stale indoor air with fresh outdoor air while transferring heat and moisture between the incoming and outgoing air streams
  • Device: Portable Air Cleaner — A standalone home device that filters indoor air to remove particulate matter, allergens, and other pollutants
  • Device: Energy Recovery Ventilator (Sham) — A home-installed ERV unit that operates in recirculation mode only, providing no fresh air exchange or heat/moisture transfer, serving as a placebo for study purposes.
  • Device: Portable Air Cleaner (Sham) — A portable air cleaner that appears to operate like an active unit but does not contain a HEPA filter and does not clean the air, serving as a placebo for study purposes

Primary Outcomes

  • Pulmonary Function (Spirometry) (Baseline; 6 months; 18 months; 24 months)
  • Asthma Control Test Score (From enrollment to the end of intervention at 1 month (24 months in total))
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-10-10
Completion: 2028-02-28
Eligibility
Age: 5 Years
Sex: ALL
Volunteers: false
Enrollment: 80 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: The University of Texas at Arlington
Collaborators: Rebuilding Together North Texas
Principal Investigators:
  • Insung Kang, Ph.D. (PRINCIPAL_INVESTIGATOR) - The University of Texas at Arlington
Contact Information
Study Contact:
Insung Kang, Ph.D.
817-272-2167
insung.kang@uta.edu
Interventions
  • Device: Energy Recovery Ventilator — A mechanical ventilation system that exchanges stale indoor air with fresh outdoor air while transferring heat and moisture between the incoming and outgoing air streams
  • Device: Portable Air Cleaner — A standalone home device that filters indoor air to remove particulate matter, allergens, and other pollutants
  • Device: Energy Recovery Ventilator (Sham) — A home-installed ERV unit that operates in recirculation mode only, providing no fresh air exchange or heat/moisture transfer, serving as a placebo for study purposes.
  • Device: Portable Air Cleaner (Sham) — A portable air cleaner that appears to operate like an active unit but does not contain a HEPA filter and does not clean the air, serving as a placebo for study purposes
Study Locations (2 sites)
University of Texas at Arlington, Arlington, Texas 76010 United States
Rebuilding Together North Texas, Plano, Texas 75025 United States
Eligibility Criteria
Inclusion Criteria: * Individuals with physician-diagnosed asthma, including both adults and children aged 5-17 * Homeowners living in the DFW metropolitan area, TX Exclusion Criteria: * Participants living in homes with any smokers
Efficacy of Indonesian Asthmatic Gymnastic as Combine Pulmonary Rehabilitation Based on Asthma Classification
NCT07480616
Recruiting
Conditions Asthma (Diagnosis), Adult
Phase NA
Enrollment 35
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

This study aims to evaluate the efficacy of Indonesian Asthma Gymnastic for stable asthmatic patients in all asthma classification. The outcome measurements includes 6 minutes walk test, Asthma Control Test, peak flow rate value, and lung function. All participants have been in routine standard treatment of asthma (medication, education of healthy life style and smoking cessation).

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Other: Indonesian Asthma Gymnastic exercise — Aerobic structured exercise designed for asthmatic patient consists of 8 phase: warming up, stretching, core movement I, core movement II, aerobics I-III, and cooling down

Primary Outcomes

  • Change in 6 minutes walk distance (Baseline, 4 weeks)
  • Asthma Control Test score (Baseline, 4 weeks)
  • Change in Forced Expiratory Volume in 1 second, Forced Vital Capacity, and FEV1/FVC ratio (Baseline, 4 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-10-06
Completion: 2026-09
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 35 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: RSUP Persahabatan
Contact Information
Study Contact:
Veronika R Kurniawati
+62 87857355235
veronikarennykurniawati@gmail.com
Interventions
  • Other: Indonesian Asthma Gymnastic exercise — Aerobic structured exercise designed for asthmatic patient consists of 8 phase: warming up, stretching, core movement I, core movement II, aerobics I-III, and cooling down
Study Locations (1 sites)
RSUP Persahabatan, Jakarta, Indonesia
Eligibility Criteria
Inclusion Criteria: * Diagnosed with stable asthma * Age 18-65 years old * Competent and willing to be included in the trial Exclusion Criteria: * Asthma exacerbation * Had other lung disease * Had neuromuscular disease affecting respiratory system
Evaluation of Clinical Effect of Acupuncture on Acute Exacerbation of Bronchial Asthma
NCT07632352
Recruiting
Conditions Bronchial Asthma
Phase NA
Enrollment 72
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Based on the bioholographic theory, this study preliminarily explores the clinical efficacy of hand acupuncture in treating acute exacerbation of bronchial asthma and evaluates its immediate anti-asthmatic effect, so as to provide a new therapeutic strategy for the clinical management of bronchial asthma.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Single

Interventions / Regimen

  • Other: Acupuncture — The acupoints selected were Kechuan point, New Kechuan point, and Yuji point. The treatment was administered once a day for 20 minutes each time, for 5 consecutive days.
  • Drug: Standard Western medicine treatment — Evaluate and manage in accordance with the Chinese Expert Consensus on Assessment and Management of Acute Exacerbation of Bronchial Asthma issued by the Asthma Group of the Chinese Thoracic Society, Chinese Medical Association in 2018 and the Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 ).

Primary Outcomes

  • Peak Expiratory Flow(PEF) (After treatment on Day 5 and follow-up at 1, 2 and 3 months)
  • Asthma Control Test (After treatment on Day 5 and follow-up at 1, 2 and 3 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-04-15
Completion: 2027-01-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 72 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Henan University of Traditional Chinese Medicine
Contact Information
Study Contact:
Qinmei Yang
15981845716
yangqinmei840105@126.com
Interventions
  • Other: Acupuncture — The acupoints selected were Kechuan point, New Kechuan point, and Yuji point. The treatment was administered once a day for 20 minutes each time, for 5 consecutive days.
  • Drug: Standard Western medicine treatment — Evaluate and manage in accordance with the Chinese Expert Consensus on Assessment and Management of Acute Exacerbation of Bronchial Asthma issued by the Asthma Group of the Chinese Thoracic Society, Chinese Medical Association in 2018 and the Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 ).
Study Locations (1 sites)
the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan 450000 China
Eligibility Criteria
Inclusion Criteria: 1. Patients meeting the Western medicine diagnostic criteria for acute exacerbation of bronchial asthma 2. Aged ≥ 18 years old 3. Voluntarily receive treatment and sign the informed consent form Exclusion Criteria: 1. Those who fail to meet the inclusion criteria 2. Patients suffering from other severe systemic diseases such as diseases of the circulatory system, hematological system and nervous system 3. Pregnant or lactating women 4. Subjects enrolled but not treated per the study protocol 5. Patients who have participated in other clinical trials of medicinal products within 3 months 6. Other circumstances deemed ineligible for enrollment by researchers
Phase II Trial of RC1416 Injection in Asthma
NCT07403487
Recruiting
Conditions Moderate to Severe Asthma
Phase PHASE2
Enrollment 195
Locations 44 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study is a phase II study of RC1416 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of RC1416 in subjects with severe uncontrolled asthma.

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Triple

Interventions / Regimen

  • Drug: RC1416 — There are two doses in this part. Each subjects will receive the drug by subcutaneous injection.
  • Drug: RC1416 Placebo — Each subjects will receive the placebo by subcutaneous injection

Primary Outcomes

  • Pre-bronchodilator (Pre-BD) forced expiratory volume in 1 Second (FEV1) (During 32 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2026-03-10
Completion: 2028-02-28
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 195 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Nanjing RegeneCore Biotech Co., Ltd.
Contact Information
Study Contact:
Guo Qian
+86-025-58608860
guoqian@regenecore.com
Interventions
  • Drug: RC1416 — There are two doses in this part. Each subjects will receive the drug by subcutaneous injection.
  • Drug: RC1416 Placebo — Each subjects will receive the placebo by subcutaneous injection
Study Locations (44 sites)
Anqiing Municipal Hospital, Anqing, Anhui 246004 China
Wanbei Coal-Electricity Group General Hospital, Suzhou, Anhui 234000 China
China-Japan Friendship Hospital, Beijing, Beijing Municipality 100029 China
The Affiliated Yongchuan Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality 402160 China
Gansu Provincial People's Hospital, Lanzhou, Gansu 730000 China
The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei 050051 China
The Affiliated Hospital of North China University of Science and Technology, Tangshan, Hebei 063000 China
Xingtai People's Hospital, Xingtai, Hebei 054001 China
The First Affiliated Hospital of Hebei North University, Zhangjiakou, Hebei 075000 China
Daqing Oilfield General Hospital, Daqing, Heilongjiang 163001 China
Eligibility Criteria
Inclusion Criteria: * Male or female aged 18 and 75 years. * Diagnosed with asthma for at least 1 year, and the current disease status meets the diagnostic criteria of the 2024 GINA guidelines. * Have received medium-to-high dose ICS therapy for at least 3 consecutive months prior to screening, and maintained a stable treatment regimen and dose for ≥1 month prior to baseline. * Pre-bronchodilator forced expiratory volume in 1 second (FEV1) measurement ≤80% of the predicted normal value at both the screening and baseline visits. * Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5 at both the screening and baseline visits. * Must have experienced ≥1 severe asthma exacerbation event within the 12 months prior to screening. * Positive bronchodilator reversibility test. Exclusion Criteria: * Individuals with a known history of allergy to the investigational product or its excipients. * Clinically diagnosed with chronic obstructive pulmonary disease (COPD) or other lung diseases that may impair lung function . * Experienced a severe asthma exacerbation event from within 1 month prior to screening until before dosing. * Used systemic corticosteroids within 1 week prior to screening. * Had a pulmonary or other site infection requiring intravenous antibiotics, antifungals, or antivirals from within 1 month prior to screening until before dosing. * Used traditional Chinese medicine with anti-asthmatic effects within 1 month prior to screening. * Underwent major surgery within 8 weeks prior to screening or plans to undergo major surgery during the study period. * With a history of malignancy within the past 5 years . * Active or incompletely treated tuberculosis * Used biologic/systemic immunosuppressant/immunomodulators within 12 weeks or 5 half-lives prior to screening. * Diagnosed active parasitic infection; suspected parasitic infection or high risk of infection. * Abnormal 12-lead electrocardiogram (ECG) at screening. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
NCT06052267
Active, positions filled
Conditions Asthma
Phase PHASE3
Enrollment 2772
Locations 393 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The primary objective of the study is to assess the efficacy of high dose fluticasone propionate (Fp)/albuterol sulfate (ABS) integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS eMDPI in decreasing severe clinical asthma exacerbation (CAEs). Secondary Objectives: To evaluate the efficacy of Fp/ABS low dose compared to ABS and the effect on systemic corticosteroid (SCS) exposure To evaluate the safety and tolerability of Fp/A BS The duration for each participant will be a minimum of 28 weeks including 2 weeks of screening, 2-4 weeks of run-in period and a double blind treatment period of minimum 24 weeks, however due to the event-driven nature of this study, the duration may range up to approximately 42 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria

Design

Study type: Interventional Phases: Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Drug: TEV-56248 — Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.
  • Drug: Albuterol sulfate — Oral inhalation powder

Primary Outcomes

  • Time to First Severe Clinical Asthma Exacerbation (CAE) with High Dose (HD) Fp/ABS eMDPI (Up to 42 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Active, positions filled
Start Date: 2023-08-30
Completion: 2026-10-31
Eligibility
Age: 4 Years
Sex: ALL
Volunteers: false
Enrollment: 2772 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Teva Branded Pharmaceutical Products R&D LLC
Principal Investigators:
  • Teva Medical Expert, MD (STUDY_DIRECTOR) - Teva Branded Pharmaceutical Products R&D LLC
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: TEV-56248 — Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.
  • Drug: Albuterol sulfate — Oral inhalation powder
Study Locations (393 sites)
Teva Investigational Site 15706, Birmingham, Alabama 35209 United States
Teva Investigational Site 15786, Birmingham, Alabama 35233 United States
Teva Investigational Site 15768, Dothan, Alabama 36305 United States
Teva Investigational Site 15581, Paradise Valley, Arizona 85258 United States
Teva Investigational Site 15710, Scottsdale, Arizona 85259 United States
Teva Investigational Site 15661, Tucson, Arizona 85741 United States
Teva Investigational Site 15685, Bakersfield, California 93301 United States
Teva Investigational Site 15721, Fresno, California 93704 United States
Teva Investigational Site 15788, Huntington Beach, California 92647-6853 United States
Teva Investigational Site 15720, La Jolla, California 92037 United States
Eligibility Criteria
Inclusion Criteria: * The participant has a documented diagnosis of asthma for at least 1 year according to the 2022 GINA guidelines. * The participant has a documented history of at least 1 severe clinical asthma exacerbation (CAE) ending within the past 12 month. * The participant is using any prescribed inhaled asthma controller medication (at a stable dose for 1 month prior to the screening visit). * If female, the participant is currently not pregnant, breastfeeding, or attempting to become pregnant (for at least 30 days before the screening visit and throughout the duration of the study), or is of nonchildbearing potential NOTE- Additional criteria apply, please contact the investigator for more information. Exclusion Criteria: * The participant has life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within 5 years before screening. * The participant has a suspected bacterial or viral infection (other than Coronavirus Disease \[COVID-19\]) of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the screening period. * Participants with a confirmed infection with COVID-19 within 6 weeks prior to the screening visit, or with residual COVID-19 symptoms ("long COVID-19"). * The participant has had a clinical asthma exacerbation (CAE) requiring systemic corticosteroids within 30 days before screening, or any hospitalization for asthma within 2 months before screening. * The participant is a current smoker and/or has a history of ≥10 pack years history of smoking. A current smoker is defined as any participant who has used any form of tobacco product (including oral) within the past 6 months. * The participant has significantly abused alcohol and/or illicit prohibited drugs within the previous 24 months. * The participant has participated as a randomized participant in any investigational drug study within 30 days. * The participant has been hospitalized for psychiatric disorder or attempted suicide within 1 year of screening. NOTE- Additional criteria apply, please contact the investigator for more information
Deployment o the Multidisciplinary Prospective Cohort Imminent
NCT04334031
Recruiting
Conditions Chronic Inflammatory Disease, Angioedema...
Phase NA
Enrollment 2200
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Immune-mediated inflammatory diseases (IMIDs) most often affect young patients and have high impact on morbidity and mortality with a significant alteration in the quality of life of patients with professional, social and emotional repercussions. Beyond this burden, IMIDs share many common pathophysiological mechanisms and treatments, known as "targeted therapies". Despite progress in this field, much remains to be done in clinical, therapeutic and fundamental research to address the efficacy, resistance and side-effects of treatment. These similarities between IMIDs have led the FHU IMMINeNT to propose the creation of a prospective, multidisciplinary clinical-biological database (IMMINeNT cohort), associated to a biobank, of patients with IMIDs. The main objectives of this database will be to identify new prognostic and therapeutic biomarkers in order to develop new therapeutic targets and biomarkers, to identify prognostic factors and determinants related to the activity, severity and quality of life of patients with IMIDs as well as to the response and tolerance to treatment.

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Other Masking/blinding: None

Interventions / Regimen

  • Genetic: Biobanking with genetic analysis — Patients included in the IMMINeNT cohort will be collected 7 blood samples for the research project at each revaluation visit. For patients who accepted, genetic analysis (DNA analysis) will be done on a part of those samples.
  • Other: SF-12 questionnaire — Patients included in the IMMINeNT cohort will be asked to complete SF-12 quality of life questionnaire.

Primary Outcomes

  • Change of SLEDAI for lupus (once a year for 10 years)
  • Change of Medsger score (once a year for 10 years)
  • Change of EDSS for multiple sclerosis (once a year for 10 years)
  • Change of BASDAI for psoriatic arthristis (once a year for 10 years)
  • Change of Longhurst criteria for hereditary angioedema (once a year for 10 years)
  • Change of number of flares for atopic dermatitis (once a year for 10 years)
  • Change of number of exacerbations for severe asthma (once a year for 10 years)
  • Change of 12-Item Short-Form Health Survey (SF-12) - quality of life scale (once a year for 10 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2020-07-20
Completion: 2031-07-21
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 2200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Hospital, Lille
Collaborators: FHU IMMINeNT, FHU PRECISE: Projet Fédératif Hospitalo-Universitaire PREcision health in Complex Immune-mediated inflammatory diseaSEs, Fond de dotation de la Société Française de Dermatologie (SFD)
Principal Investigators:
  • David Launay, MD,PhD (PRINCIPAL_INVESTIGATOR) - University Hospital, Lille
Contact Information
Study Contact:
David Launay, MD,PhD
03 20 44 42 95
david.launay@chru-lille.fr
Interventions
  • Genetic: Biobanking with genetic analysis — Patients included in the IMMINeNT cohort will be collected 7 blood samples for the research project at each revaluation visit. For patients who accepted, genetic analysis (DNA analysis) will be done on a part of those samples.
  • Other: SF-12 questionnaire — Patients included in the IMMINeNT cohort will be asked to complete SF-12 quality of life questionnaire.
Study Locations (1 sites)
Hop Claude Huriez Chu Lille, Lille, 59037 France
Eligibility Criteria
Inclusion Criteria: * Patient followed for their IMID in one of the departments of the Lille University Hospital participating in the study (dermatology, internal medicine, neurology, pneumology and rheumatology) * Social insured * Have the capacity to understand the study requirements, provide written informed consent, and comply with the study data collection procedures. Exclusion Criteria: * Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system. * Pregnant or breastfeeding woman * Persons deprived of liberty * Protected minors or adults * Persons who have refused or are incapable of giving informed consent * Persons in Emergency Situations