Recruiting
A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
The main aim of the study to describe the characteristics of participants with asthma across the spectrum of disease severity, including sociodemographic and clinical characteristics, treatment and disease burden, biomarkers, and both disease-specific and generic health-related quality of life. The study consists of two parts: a cross-sectional study, and a prospective follow-up evaluate changes in disease trajectories in participants with asthma.
ClinicalTrials.gov IDNCT07556159
PhaseNot Applicable
Enrollment2500
SponsorSanofi
Age6 Years
SexALL
Conditions studied
Asthma
About this study
The main aim of the study to describe the characteristics of participants with asthma across the spectrum of disease severity, including sociodemographic and clinical characteristics, treatment and disease burden, biomarkers, and both disease-specific and generic health-related quality of life. The study consists of two parts: a cross-sectional study, and a prospective follow-up evaluate changes in disease trajectories in participants with asthma.
Interventions
- Other: Procedure: Investigational Procedures — Participant- and physician-reported outcomes will be collected per protocol. No Investigational Medicinal Product (IMP) administration.
- Other: Procedure: Investigational Procedures — Participant- and physician-reported outcomes, blood samples/lung tests and other optional assessments will be collected per protocol. No IMP administration.
Primary outcomes
- Part 1: Descriptive Characterization of Participants With Asthma Across the Spectrum of Severities (Part 1: At baseline)
- Part 1: ACQ-5 Scores to Evaluate Characteristics of Participants With Asthma (Part 1: At baseline)
- Part 1: Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Scores to Evaluate Characteristics of Participants With Asthma (Part 1: At baseline)
- Part 1: Physician Global Assessment of Asthma Severity and Symptom Control (Part 1: At baseline)
- Part 2: Descriptive Statistical Analysis of Difference in Asthma Symptom Control (ACQ-5) Between Part 2 Cohorts A1 and A2 (Part 2: At Weeks 52 and 104)
- Part 2: Number of Participants Analyzed with Treatment Utilization Pattern between Part 2 Cohorts A1 and A2 (Part 2: At Weeks 52 and 104)
- Part 2: Descriptive Statistical Analysis of Difference in Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV₁) between Part 2 Cohorts B1 and Cohort B2 (Part-2: At Weeks 52 and 104)
Eligibility information
Inclusion Criteria:
Applicable for Part 1 participants:
* Age 6 years and older, at the time of signing the informed consent
* Physician diagnosis of asthma for at least 12 months
* Existing treatment with low, medium, or high dose ICS and other asthma therapies as reflected in GINA 2-5 steps
* Participant or legally authorized representative (where applicable) has consented to participate
Applicable for Part 2 participants:
* Age 18 years and older, at the time of signing the informed consent.
* Physician diagnosis of asthma for at least 12 months
* Existing treatment with low or medium ICS and other asthma therapies as reflected in GINA 2-4 steps
* Participant or legally authorized representative (where applicable) has consented to participate
* Participants must meet the criteria for at least one of the cohorts below:
A) Asthma control cohorts
1. ACQ-5 \>= 1.5
2. ACQ-5 \< 1.5 (B) Type-2 biomarker cohorts
3. Elevated T2 biomarkers (B1: Type-2-high cohort)
4. Low T2 biomarkers (B2: Type-2-low cohort)
Participants are excluded from the study if any of the following criteria apply (applicable for both Part 1 and Part 2 participants):
* Current diagnosis of chronic obstructive pulmonary disease (COPD) or congestive heart failure
* Participants with moderate/severe cognitive impairment.
* Participants with moderate/severe cardiac disease.
* Participants on immunosuppressive medication for a chronic condition.
* Participation in other interventional and noninterventional clinical study (currently or in the past 3 months)
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Study locations
- Chandler Clinical Trials - Site Number: 840106, Chandler, Arizona 85224 United States
- Del Sol Research Management, LLC - Mesa - Site Number: 840123, Mesa, Arizona 85206 United States
- Sun City Clinical Trials - Elite - Site Number: 840120, Sun City, Arizona 85351 United States
- FOMAT - Huntington Asthma & Allergy Center - Site Number: 840158, California City, California 91107 United States
- Imax Clinical Trials - Site Number: 840109, La Palma, California 90623 United States
- Downtown LA Research - Site Number: 840161, Los Angeles, California 90017 United States
- Newport Native MD, Inc. - Site Number: 840101, Newport Beach, California 92663 United States
- Pasadena Clinical Trials - Site Number: 840116, Pasadena, California 91101 United States
- Valiance Clinical Research (JPJ Research) - Site Number: 840135, Tarzana, California 91356 United States
- Clinical Research of California - Site Number: 840145, Walnut Creek, California 94598 United States
Showing 10 of 62 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.