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
Sanofi
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 range
- 6+ years
- Sex
- All
- Healthy volunteers
- No
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 I…
Interventions
- OtherProcedure: Investigational Procedures
Participant- and physician-reported outcomes will be collected per protocol. No Investigational Medicinal Product (IMP) administration.
- OtherProcedure: Investigational Procedures
Participant- and physician-reported outcomes, blood samples/lung tests and other optional assessments will be collected per protocol. No IMP administration.
Locations (4)
- Clinical Research of California - Site Number: 840145Walnut Creek, California
- L&A Morales Healthcare, Inc - Site Number: 840102Miami, Florida
- Montana Medical Research - Site Number: 840137Missoula, Montana
- Pioneer Research Solutions - Site Number: 840104Houston, Texas