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About This Study

Women with polysyctic ovarian syndrome (PCOS) usually develop many complications including asthma. Nowdays, diet restriction combimed with phsyical exercises may improve both problems

Design

Interventions / Regimen

• Behavioral: exercise plus limiitng diet — Group I will enroll twenty females with PCOS and asthma who will apply forty minutes walking on treadmill three times per week. Also Group I will follow low calorie diet and daily metformin for 12 weeks.
• Behavioral: limiting diet — Group II will will enroll twenty females with PCOS and asthma who will follow low calorie diet and daily metformin for 12 weeks

Primary Outcomes

• forced vital capcity (it will be measured after 12 weeks)

About This Study

The International Severe Asthma Registry is a global initiative looking to ensure that the care of people with severe asthma will continue to improve by collecting detailed information about the health and treatment of as many people with the disease as possible. The study will gather anonymized longitudinal real-life data for participants with severe asthma for five years. The purpose of the registry is to track the progress of participants and determine how well they are responding to treatment. Medical research using data from the registry will give the investigators a better understanding of severe asthma and help the investigators develop and improve the care and treatment for severe asthma participants. The Canadian cohort of the registry will collect information from Canadian participants with severe asthma across seven different sites.

Design

Primary Outcomes

• Blood eosinophil counts (Past 12 months)
• Blood Immunoglobulin E (IgE) counts (Past 12 months)
• Fractional exhaled nitric oxide level (Past 12 months)
• Start and end dates of oral corticosteroid medication (Prior to baseline visit)
• Asthma Control (Past 4 weeks)
• Start and end dates of biologic medications such as anti-interleukin-5, anti-immunoglobulin E, or anti-interleukin-4 treatments (if relevant) (Prior to baseline visit)
• Reason for switching biologic medication (if relevant) (Past 12 months)
• Start and end dates of all asthma related inhaled medications (Prior to baseline visit)

About This Study

This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential efficacy of ENV-294 in adults with moderate to severe asthma who are receiving background treatment with inhaled corticosteroids (ICS) and long-acting beta₂-agonists (LABA). Participants will take oral ENV-294 or placebo once daily for 12 weeks. The study includes a screening period of up to 28 days before randomization to confirm eligibility. Study visits and assessments will be conducted to monitor safety, measure drug levels in the blood, and evaluate effects on asthma control and lung function.

Design

Interventions / Regimen

• Drug: ENV-294 — ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
• Drug: Placebo — Matching oral tablet that does not contain active drug. Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.

Primary Outcomes

• Incidence and Severity of Adverse Events (From first dose through approximately 16 weeks)

About This Study

The study will evaluate the feasibility of using smartphone speakers and microphones to evaluate the caliber of the airways, detect airway obstruction, aid in airway disease diagnosis, and identify disease exacerbations.

Design

Interventions / Regimen

• Diagnostic Test: AWARE — AWARE testing to estimate lung function and aid in disease diagnosis

Primary Outcomes

• Accurate and reliable disease diagnosis (Up to two weeks per subject)
• Estimation of FEV1 (Up to two weeks per subject)
• Estimation of FVC (Up to two weeks per subject)
• Estimation of FEV1/FVC (Up to two weeks per subject)
• Estimation of FEF2575 (Up to two weeks per subject)
• Estimation of R5 (Up to two weeks per subject)
• Estimation of R20 (Up to two weeks per subject)
• Estimation of R5-R20 (Up to two weeks per subject)

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 population health management (PHM; asthma community health worker, asthma nurse care manager) implementation strategies building on electronic medical record clinical decision support and education implementation strategies (CDS+), to increase adoption of SMART. This is the second of two related records.

Design

Interventions / Regimen

• Behavioral: Clinical decision support + education (CDS+) and population health management (PHM) — In Interval 1, 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+). In Interval 2, intervention clinics will have CDS+ and population health management (PHM) strategies, including an asthma community health worker and an asthma nurse care manager.
• 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 1 (CDS+; 11 months), Interval 2 (CDS+ and PHM; 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).)

About This Study

The detection of exhaled nitric oxide (FeNO) represents a non-invasive, safe, and rapid approach for assessing endogenous nitric oxide (NO) levels within the airway. FeNO concentrations are closely associated with airway inflammation and hyperresponsiveness, and are currently recognized as biomarkers indicative of type II airway inflammation. Recent advancements in nitric oxide detection technology for both upper and lower airways, as well as for small and large airways, have provided significant insights for the diagnosis and management of conditions such as bronchial asthma, chronic cough, upper airway diseases, chronic obstructive pulmonary disease, and even rare airway disorders. Presently, FeNO measurement is frequently employed in the differential diagnosis and monitoring of airway inflammatory diseases. The FeNO test is conducted using a FeNO test analyzer. Internationally, FeNO detection analyzers utilize three primary methodologies: chemiluminescence, laser, and electrochemical techniques. Among these, chemiluminescence is regarded as the "gold standard" globally. However, due to technical constraints, this methodology has not been clinically accessible within domestic settings. In China, the electrochemical FeNO analyzer is predominantly utilized, characterized by its compact size and portability. Nonetheless, this method necessitates patient cooperation during inhalation and exhalation, rendering it impractical for individuals who are unable to comply, such as children, the elderly, and severely ill patients. Consequently, FeNO detection poses significant challenges for these populations in China, representing a notable clinical gap. The newly implemented technology employs an innovative domestic chemiluminescence FeNO analyzer, which is exclusively available in China. This analyzer, owing to its methodological advantages, is capable of obtaining FeNO detection values from patients' natural breathing patterns, facilitating rapid response and comprehensive FeNO assessment without requiring patient cooperation. This approach, referred to as the "Tidal-breathing of FeNO" enables the completion of FeNO assessments in patients who are unable to engage in inspiratory and expiratory maneuvers. This advancement is anticipated to enhance the diagnostic accuracy of airway inflammation in this demographic, thereby facilitating early diagnosis, precise treatment, and improved management of disease progression.

Design

Interventions / Regimen

• Diagnostic Test: Chemiluminescent FeNO Analyzer — A novel chemiluminescence FeNO Analyzer has been developed, capable of measuring both FeNO50 and FeNO during tidal breathing. Each participant underwent three testing sessions, with the results averaged, and the sequence of tests was randomized.
• Diagnostic Test: Electrochemical FeNO Analyzer — Electrochemical FeNO analyzers are employed in clinical settings for the measurement of FeNO50. Each participant underwent three testing sessions, with the results averaged, and the sequence of tests was randomized.

Primary Outcomes

• Performance Assessment of FeNO Chemiluminescence Analyzer (Through study completion, an average of 6 months)

About This Study

The intervention program targets adolescents between 12 and 16 years of age. The intervention program is designed for adolescents during a critical developmental stage marked by significant life transitions, where building strong personal resources and receiving psychological support is essential to foster socioemotional skills and overall well-being. The serious game aims to promote psycho-emotional health in the general adolescent population, supporting healthy development and preventing future emotional difficulties. At the same time, it incorporates specific modules for adolescents living with chronic conditions such as asthma, food allergy, type 1 diabetes, and allergic rhinitis, who may face additional risks of psychological challenges that can complicate treatment and prognosis. By combining universal health promotion with tailored support, the program addresses both the needs of healthy adolescents and those with chronic illnesses. The platform integrates digital and technological tools for dynamic and personalized intervention. Artificial intelligence adapts activities and feedback to each participant's socio-demographic profile and evolving needs, this supports directly in participants' daily lives and natural environments, making the experience more relevant and impactful. The serious game, proven effective in engaging young people, goes beyond traditional psychoeducation by creating an interactive environment where adolescents develop socio-emotional competencies, resilience, and health-related knowledge. Through its six thematic areas, the game promotes overall well-being and healthy habits, while its condition-specific modules provide targeted guidance and coping strategies for asthma, food allergies, type 1 diabetes, and allergic rhinitis.

Design

Interventions / Regimen

• Behavioral: EmoTIChealth — The EmoTIChealth technological platform intervenes in users through a "serious game", i.e. a video game whose main purpose is to teach or provide the player with certain skills that serve to achieve a higher purpose than the game itself. The game is composed of 6 areas, each of which refers to one of the variables that are analyzed or considered important in promoting health related quality of life and adaptation to chronic illness: Area 1. Psychoeducation; 2. Emotional awareness and expression; 3. Emotional regulation; 4. Problem solving; 5. Self-esteem and identity;6. Social skills and communication.

Primary Outcomes

• Change Quality of Life (Baseline-Pre-Post) (Baseline up to 8 weeks)
• Change Emotional and Behavioral Problems (Baseline-Pre-Post) (Baseline up to 8 weeks)
• Change Emotional Competences (Baseline-Pre-Post) (Baseline up to 8 weeks)
• Change Self-concept (Baseline-Pre-Post) (Baseline up to 8 weeks)
• Change Coping (Baseline-Pre-Post) (Baseline up to 8 weeks)
• Change Social Skills (Baseline-Pre-Post) (Baseline up to 8 weeks)

About This Study

Chronic lung diseases affect one in five Canadians, causing symptoms such as cough, breathlessness, and wheeze. Despite advancements in medical care, these conditions not only impact individuals and their close circles but also present substantial clinical and economic challenges at a national level. This grant is dedicated to addressing three prevalent lung diseases: asthma, chronic obstructive pulmonary disease (COPD), and chronic cough. An alliance of clinicians, scientists, knowledge users, and patient partners from across Canada have come together to establish the Canadian Consortium for Understanding the Role of Airway Mucus Occlusions in Asthma, COPD, and Chronic Cough - "CANMuc." Mucus plays a pivotal role in the symptoms and severity of lung diseases, but its clinical assessment has been challenging. Fortunately, recent medical advances, particularly chest computed tomography (CT), facilitate visualizing and quantifying mucus in patients with lung diseases. Our goal is to initially assess mucus plugging in a diverse group of Canadians without lung disease and then compare these findings to those with asthma, COPD, and chronic cough. The investigators will recruit 100 healthy volunteers for comprehensive clinical and research evaluations, including sputum analyses, breathing tests, quality of life assessments, cough monitoring, and CT scans. In addition, testing will be conducted twice, two years apart, in 240 adult and 50 pediatric participants. This approach will enable the investigators to understand the burden of mucus and how it changes over time, explore proteins or chemicals in mucus that predict mucus persistence, and identify biomarkers that can help guide physicians to prescribe targeted treatments that might work better than others. The CANMuc team's findings will guide strategies for identifying and treating mucus plugging, inform policymakers, and share knowledge with Canadians living with asthma, COPD, and chronic cough.

Design

Interventions / Regimen

• Other: Observational — This is a 24-month observational study in adults in three disease domains, consisting of screening visit, baseline visit, quarterly telemonitoring visit and end of monitoring period

Primary Outcomes

• Computed Tomography mucus score (Baseline/Day 0 and End of Assessment/48 months)

About This Study

While asthma therapy is becoming more individualized based on asthma phenotypes, more research is needed to tailor newer therapies to individuals. Inhaled corticosteroid (ICS) medications are the foundation of care for all individuals with persistent asthma. But ICS use is not without possible long term side effects. This study will compare two currently available approaches to reduce AEX in primary care patients: (1) use of inhaled corticosteroids (ICS) as part of rescue therapy, also known as MART (Maintenance And Reliever Therapy) or PARTICS (Patient Activated Reliever Trigger Inhaled Corticosteriods) therapy - either of these therapies will be called Rescue-Inhaled Corticosteroids or R-ICS pronounced "Ricks," and (2) use of azithromycin (AZ) as a preventive therapy. These treatments will be studied both individually and in combination.

Design

Interventions / Regimen

• Drug: Inhaled corticosteroid (ICS) — Participants will use either a combination of budesonide/formoterol or mometasone/formoterol as both controller and rescue therapy or a stand alone inhaled steroid (beclomethasone, budesonide, fluticasone, mometasone, ciclesodine) of their choice with their current reliever therapy or be converted to budesonide/albuterol as rescue therapy.
• Drug: Azithromycin — Participants will take 500mg of azithromycin three times a week or 10mg/kg if under 50Kg which may be reduced to 250mg/Kg for side effects.
• Other: Asthma Symptom Monitoring Web-based Application — All participants will be provided access to the Asthma Symptom Monitoring (ASM) tools. ASM can be integrated with electronic health records (EHR) or used as a stand alone application. Participants will answer 5 questions about their asthma each week. If symptoms are problematic, participants can request a call back from a person on their care team. Participants can view a graph of their data, watch videos, and record peak flows. Clinicians and members of the care team can view data in the EHR (not for stand alone web app).

Primary Outcomes

• Rate of Asthma Exacerbations Per Year (Follow-up is up to 16 months.)

About This Study

Plant stanols are known to lower low-density lipoprotein cholesterol. However, studies have suggested that these compounds also influence the immune system. Asthmatic responses are predominantly T helper (Th)2 cell dependent, while plant stanols were previously found to activate Th1 cells and shift the immune response away from the Th2 cell dominant asthmatic response. The question now is whether this also translates into a reduction of clinical symptoms in asthma patients.The primary objective of this study is to demonstrate clinical benefits of prolonged consumption of plant stanols (delivered via plant stanol esters) in asthma patients. The secondary objectives are to evaluate the mechanisms via which plant stanols modulate the immune system and to evaluate the effects of plant stanol ester consumption on cardiovascular (CVD) risk parameters.

Design

Interventions / Regimen

• Dietary Supplement: Soft chews containing 0.5g plant stanols (delivered as plant stanol esters) — Soft chews containing 0.5g plant stanols delivered as plant stanol esters
• Dietary Supplement: Placebo soft chew — Soft chew that does not contain plant stanols

Primary Outcomes

• Asthma control questionnaire score (Change between T=0 months and T=12 months)

About This Study

The goal of this clinical trial is to learn if community-based exercise training can benefit patients aged 18 to 85 with diminished cardiovascular and pulmonary function. The main aim of this study is: • Establish a community or home-based fitness training program for patients with cardiopulmonary insufficiency to improve adherence, safety, and efficacy while alleviating the burden on both patients and society. Researchers will compare community-based exercise training to non-exercise training to see if community-based exercise training works to improve cardiovascular and pulmonary function. Participants will: * Engage in community or home exercise training for 40-60 minutes, five times weekly, during a duration of eight weeks. Exercise modalities are primarily determined by the patients' individual preferences and habits, such as brisk walking, running, swimming, cycling, and hiking. * Adjust the exercise intensity according to their cardiopulmonary exercise test and the person's perceived exertion level. * Utilize fitness bracelets or watches to document statistics during workouts and submit them to the experimenter weekly, covering the five days of exercise within that week. * refrain from making any dietary modifications throughout the trial.

Design

Interventions / Regimen

• Behavioral: community-based exercise training — The patients will engage in 40-60 minutes of exercise training, either at home or in the community, five times a week, for eight weeks. Brisk walking, jogging, swimming, cycling, and trekking were among the exercise modalities that were chosen mostly based on the patient's individual preferences and habits. To guarantee safe and efficient exercise, exercise intensity was modified based on each person's subjective effort level and the results of their individual cardiorespiratory exercise tests.

Primary Outcomes

• exercise capacity (at enrollment and week 8)
• exercise capacity (at enrollment and week 8)
• life quality (at enrollment and week 8)

About This Study

This is a prospective, non-interventional, single-arm, multicenter study to investigate asthma control, and health-related quality of life (HRQL), lung function and asthma medication intake in severe eosinophilic asthma patients treated with benralizumab in a real-life setting in Germany.

Design

Primary Outcomes

• Change in Asthma Control Test (ACT) total score in patients from baseline to week 12, 24 and 52 after first benralizumab dose (From baseline to week 12, 24 and 52)
• Proportion of responders at baseline, week 12, 24 and 52 after first benralizumab dose, using ACT (At baseline, week 12, 24 and 52)
• Change in daily doses of prescribed inhaled corticosteroids (ICS) intake from baseline to week 12, 24 and 52 after first benralizumab dose (From baseline to week 12, 24 and 52)
• Change in daily doses of patient-reported inhaled corticosteroids (ICS) intake from baseline to week 12, 24 and 52 after first benralizumab dose (From baseline to week 12, 24 and 52)
• Reduction (in percentage) in prescribed daily ICS dose intake from baseline to week 52 after first benralizumab dose (From baseline to week 52)
• Reduction (in percentage) in patient-reported daily ICS dose intake from baseline to week 52 after first benralizumab dose (From baseline to week 52)