Understanding asthma characteristics and outcomes in routine care
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
This project will collect information and follow people with asthma to see how symptoms, treatments, biomarkers, and quality of life change over time, especially among those using inhaled corticosteroids.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Locations | 4 sites (Walnut Creek, California and 3 other locations) |
| Trial ID | NCT07556159 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people with a physician diagnosis of asthma for at least 12 months who are receiving inhaled corticosteroids and can attend study visits, with Part 1 open to ages 6+ and Part 2 to adults 18+.
Not a fit: Patients without a year-long asthma diagnosis, not using inhaled corticosteroids as specified, or unable to participate in follow-up visits are unlikely to gain direct benefit from participation.
Why it matters
Potential benefit: If successful, this work could help tailor asthma care by identifying patterns in symptoms, biomarkers, and treatment responses that inform personalized management.
How similar studies have performed: Prior observational cohorts and registries have yielded useful phenotype and biomarker insights in asthma, though large longitudinal multicenter datasets focused on inhaled corticosteroid-treated populations are less common.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Walnut Creek, California and 3 other locations
- Clinical Research of California - Site Number: 840145 — Walnut Creek, California, United States (Recruiting)
- L&A Morales Healthcare, Inc - Site Number: 840102 — Miami, Florida, United States (Recruiting)
- Montana Medical Research - Site Number: 840137 — Missoula, Montana, United States (Recruiting)
- Pioneer Research Solutions - Site Number: 840104 — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Trial Transparency email recommended-Toll free for US & Canada
- Email: Contact-US@sanofi.com
- Phone: 800-633-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.