Actively Recruiting
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
Led by Sanofi · Updated on 2026-04-29
2500
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sanofi
Lead Sponsor
S
Syneos Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the characteristics and outcomes of people with asthma, covering a wide range of disease severities. This study aims to describe participants' social and clinical profiles, treatment experiences, disease burden, biomarkers, and quality of life. It includes two parts: a cross-sectional study and a prospective follow-up to observe changes in disease progression over time. Participants continue their usual asthma care with treatments such as low, medium, or high doses of inhaled corticosteroids and/or biologic therapies. The study groups include participants with varying asthma control levels based on the Asthma Control Questionnaire-5 (ACQ-5) scores and different levels of type-2 biomarkers. No investigational drugs are given; instead, participant- and physician-reported outcomes along with blood samples and lung tests are collected. During the study, participants provide information through questionnaires and undergo assessments like lung function tests and blood sampling. Researchers measure asthma control, quality of life, symptom severity, treatment patterns, exacerbation rates, and healthcare resource use at various time points, including baseline, week 52, and week 104. The study follows participants over two years to understand disease evolution and treatment outcomes in real-world clinical practice.
CONDITIONS
Brief Title
A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For Part 1: Age 6 years or older at consent
- For Part 1: Physician diagnosis of asthma for at least 12 months
- For Part 1: Currently treated with low, medium, or high dose inhaled corticosteroids and other asthma therapies per GINA steps 2-5
- For Part 1: Participant or legally authorized representative has consented
- For Part 2: Age 18 years or older at consent
- For Part 2: Physician diagnosis of asthma for at least 12 months
- For Part 2: Currently treated with low or medium dose inhaled corticosteroids and other asthma therapies per GINA steps 2-4
- For Part 2: Participant or legally authorized representative has consented
- For Part 2: Meets criteria for at least one cohort: ACQ-5 score �31.5, ACQ-5 score < 1.5, elevated T2 biomarkers, or low T2 biomarkers
You will not qualify if you...
- Current diagnosis of chronic obstructive pulmonary disease (COPD) or congestive heart failure
- Moderate to severe cognitive impairment
- Moderate to severe cardiac disease
- Taking immunosuppressive medication for a chronic condition
- Participation in other interventional or noninterventional clinical study currently or within past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At baseline
Participants undergo assessments including blood samples, lung function tests, and completion of participant- and physician-reported outcomes to characterize asthma and disease burden.
1 baseline visit (in-person)
Duration - Up to 104 weeks
Participants are followed over time to observe asthma symptom control, treatment patterns, lung function, and disease outcomes in routine clinical practice.
Visits at Weeks 52 and 104
Trial Site Locations
Total: 4 locations
1
Clinical Research of California - Site Number: 840145
Walnut Creek, California, United States, 94598
Actively Recruiting
2
L&A Morales Healthcare, Inc - Site Number: 840102
Miami, Florida, United States, 33142
Actively Recruiting
3
Montana Medical Research - Site Number: 840137
Missoula, Montana, United States, 59808
Actively Recruiting
4
Pioneer Research Solutions - Site Number: 840104
Houston, Texas, United States, 77099
Actively Recruiting
Research Team
T
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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