Trials / Active Not Recruiting
Active Not RecruitingNCT04550962
Description of Characteristics, Such as Age, Previous and Concurrent Treatments, Associated Diseases, of Patients With Asthma Treated With Dupilumab (DUPIXENT)
PRospEctiVe charactErization of Asthma Patients Treated With DupilumAb in reaL World Setting
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 376 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: The primary objective of the study is to characterize patients initiating DUPIXENT for asthma in a real-world setting, with respect to their medical history, including asthma history and asthma treatment history, socio-demographic, biomarkers (including Fractional exhaled nitric oxide \[FeNO\]), and concomitant treatments for asthma. Secondary Objectives: The secondary objectives of the study are: * To characterize real-world use patterns of DUPIXENT for asthma (eg, most commonly used regimens, reason for initiation of new asthma treatments, concomitant therapies, treatment durations, and reasons for discontinuation and/or switching) * To assess the effectiveness of DUPIXENT in asthma patients in a real world setting (lung function improvement, exacerbation rate, asthma control) * To assess comorbid type 2 conditions (atopic/allergic) and patterns of use and effects of treatment in comorbid conditions in asthma patients treated with Dupixent * To collect data on HealthCare Resource Utilization (HCRU) * To collect safety data on study participants in the real-world setting.
Detailed description
Each patient will be followed for up to 36 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dupilumab SAR231893 | Pharmaceutical form:solution Route of administration: subcutaneous Dose regimen: |
Timeline
- Start date
- 2020-11-02
- Primary completion
- 2026-07-01
- Completion
- 2026-07-01
- First posted
- 2020-09-16
- Last updated
- 2026-02-12
Locations
41 sites across 12 countries: Argentina, Chile, Colombia, Israel, Kuwait, Lebanon, Mexico, Qatar, Russia, Saudi Arabia, Singapore, United Arab Emirates
Source: ClinicalTrials.gov record NCT04550962. Inclusion in this directory is not an endorsement.