Description of Characteristics, Such as Age, Previous and Concurrent Treatments, Associated Diseases, of Patients With Asthma Treated With Dupilumab (DUPIXENT)
- Registration Number
- NCT04550962
- Lead Sponsor
- Sanofi
- Brief 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 during 36 months.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 375
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with asthma Dupilumab SAR231893 Eligible participants are initiating treatment with Dupixent for asthma according to the prescribing information in effect in each country
- Primary Outcome Measures
Name Time Method Baseline Characteristics: Disease characteristics At baseline Baseline Characteristics: Medical history At baseline Including asthma history and asthma treatment history.
Baseline Characteristics: Socio-demographics At baseline Baseline Characteristics: Concomitant treatments for asthma At baseline
- Secondary Outcome Measures
Name Time Method Lung function Baseline to Month 54 Pre and post bronchodilator (BD) forced expiratory volume in 1 second (FEV1) over time.
Number of participants with adverse events (AE) and serious adverse events (SAE) Baseline to Month 54 Healthcare Resource Utilization Baseline to Month 54 The Healthcare Resource Utilization (HCRU) is a questionnaire filled out by the participating site at baseline and at clinical visits (scheduled and unscheduled) throughout the study.
Annualized exacerbation rate Baseline to Month 54 An Exacerbation event is defined as a deterioration of asthma requiring:
* Use of systemic corticosteroids for ≥3 days; or
* Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.Dupixent and other asthma treatment use patterns Baseline to Month 54 Including doses and dose frequency, treatment duration, asthma treatment associations (eg, Dupixent monotherapy, Dupixent + inhaled corticosteroids (ICS), Dupixent + ICS + additional controllers, oral corticosteroid (OCS) burst), and reasons for initiation and for discontinuation/switching.
Patient reported outcomes Baseline to Month 54 For asthma and type 2 comorbidities over time.
Trial Locations
- Locations (41)
Investigational Site Number : 4140001
🇰🇼Kuwait, Kuwait
Investigational Site Number : 0320004
🇦🇷Santa Fe, Argentina
Investigational Site Number : 1700009
🇨🇴Barranquilla, Colombia
Investigational Site Number : 3760001
🇮🇱Kfar Saba, Israel
Investigational Site Number : 4220003
🇱🇧Achrafieh, Lebanon
Investigational Site Number : 4220001
🇱🇧Beirut, Lebanon
Investigational Site Number : 1700003
🇨🇴Bucaramanga, Colombia
Investigational Site Number : 3760008
🇮🇱Ashdod, Israel
Investigational Site Number : 3760007
🇮🇱Tel Aviv, Israel
Investigational Site Number : 4840003
🇲🇽Durango, Mexico
Investigational Site Number : 6340001
🇶🇦Doha, Qatar
Investigational Site Number : 6430005
🇷🇺Chelyabinsk, Russian Federation
Investigational Site Number : 1520002
🇨🇱Quillota, Valparaíso, Chile
Investigational Site Number : 0320005
🇦🇷La Plata, Buenos Aires, Argentina
Investigational Site Number : 0320009
🇦🇷San Miguel de Tucuman, Argentina
Investigational Site Number : 1520001
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 3760005
🇮🇱Jerusalem, Israel
Investigational Site Number : 0320006
🇦🇷Villa Rosa, Buenos Aires, Argentina
Investigational Site Number : 0320008
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Investigational Site Number : 3760004
🇮🇱Ashkelon, Israel
Investigational Site Number : 0320001
🇦🇷Ciudad Autonoma Bs As, Argentina
Investigational Site Number : 1700004
🇨🇴Bogota, Colombia
Investigational Site Number : 3760003
🇮🇱Jerusalem, Israel
Investigational Site Number : 6820002
🇸🇦Riyadh, Saudi Arabia
Investigational Site Number : 6820001
🇸🇦Riyadh, Saudi Arabia
Investigational Site Number : 7020002
🇸🇬Singapore, Singapore
Investigational Site Number : 3760006
🇮🇱Rehovot, Israel
Investigational Site Number : 4220002
🇱🇧Beirut, Lebanon
Investigational Site Number : 6430002
🇷🇺Stavropol, Russian Federation
Investigational Site Number : 7020001
🇸🇬Singapore, Singapore
Investigational Site Number : 7840004
🇦🇪Sharjah, United Arab Emirates
Investigational Site Number : 6820005
🇸🇦Jeddah, Saudi Arabia
Investigational Site Number : 6430007
🇷🇺Moscow, Russian Federation
Investigational Site Number : 6430004
🇷🇺Moscow, Russian Federation
Investigational Site Number : 6430006
🇷🇺Rostov-on-Don, Russian Federation
Investigational Site Number : 7840007
🇦🇪Dubai, United Arab Emirates
Investigational Site Number : 7840001
🇦🇪Dubai, United Arab Emirates
Investigational Site Number : 6430008
🇷🇺Saratov, Russian Federation
Investigational Site Number : 6820004
🇸🇦Makkah, Saudi Arabia
Investigational Site Number : 7840002
🇦🇪Sharjah, United Arab Emirates
Investigational Site Number : 7840006
🇦🇪Abu Dhabi, United Arab Emirates