A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
A Hybrid Cross-sectional and Prospective Study to Assess Patient Characteristics, Disease Burden, Disease Control, Phenotypes, Endotypes, and Outcomes in a Real-world Setting in Patients With Asthma
Who can join
Ages 6 and older · All sexes
Full eligibility criteria
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.
About the 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.
What is being tested
- Procedure: Investigational Procedures (other)
- Procedure: Investigational Procedures (other)
Sponsor: Sanofi · Participants: 2,500 · Started: Apr 1, 2026
Contact the study team
- Trial Transparency email recommended-Toll free for US & Canada · Phone: 800-633-1610
Official record on ClinicalTrials.gov — NCT07556159
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.