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A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice

RECRUITINGSponsored by Sanofi
Actively Recruiting
SponsorSanofi
Started2026-04-01
Est. completion2029-04-04
Eligibility
Age6 Years+
Healthy vol.Accepted
Locations4 sites

Summary

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.

Eligibility

Age: 6 Years+Healthy volunteers accepted
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.

Conditions1

Asthma

Locations4 sites

California

1 site
Clinical Research of California - Site Number: 840145
Walnut Creek, California, 94598

Florida

1 site
L&A Morales Healthcare, Inc - Site Number: 840102
Miami, Florida, 33142

Montana

1 site
Montana Medical Research - Site Number: 840137
Missoula, Montana, 59808

Texas

1 site
Pioneer Research Solutions - Site Number: 840104
Houston, Texas, 77099

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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