Understanding asthma characteristics and outcomes in routine care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, multicenter project enrolls participants with physician-diagnosed asthma to capture sociodemographic and clinical characteristics across the spectrum of disease severity. It includes a cross-sectional component collecting baseline data on symptoms, treatments (including low-to-high dose inhaled corticosteroids), biomarkers, and disease-specific and generic health-related quality of life, plus a prospective follow-up to track changes in disease trajectories. Participants are allocated into cohorts by asthma control (ACQ-5) and Type-2 biomarker status, with Part 1 open to ages 6+ and Part 2 limited to adults 18+. Data are collected at multiple U.S. clinic sites and coordinated by industry sponsors to generate real-world phenotype and outcome data.

Why it matters

Who can join: the full rules

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.

Where it's running

• Trinity Clinical Research, LLC - Bessemer - Site Number: 840150
  Bessemer, Alabama, United States Recruiting
• Orso Health - Scottsdale - Site Number: 840133
  Scottsdale, Arizona, United States Recruiting
• Columbia Medical Practice - Site Number: 840172
  Columbia, Maryland, United States Recruiting
• University of Michigan - Ann Arbor - Site Number: 840140
  Ann Arbor, Michigan, United States Recruiting
• East Carolina University Physicians - Pulmonary and Critical Care Medicine - Site Number: 840142
  Greenville, North Carolina, United States Recruiting
• Investigational Site Number: 124203
  Calgary, Alberta, Canada Recruiting

+33 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial Transparency email recommended-Toll free for US & Canada
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.