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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04550962
Other study ID # OBS16688
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2, 2020
Est. completion date December 21, 2026

Study information

Verified date January 2024
Source Sanofi
Contact Trial Transparency email recommended (Toll free number for US &
Phone 800-633-1610
Email Contact-Us@sanofi.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

Each patient will be followed during 36 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date December 21, 2026
Est. primary completion date December 21, 2026
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility - Male or female, 12 years or older Initiating treatment with Dupixent for asthma according to the country-specific prescribing information Willing and able to comply with the required clinic visits, study procedures and assessments. Provided signed informed consent - Most important exclusion criteria for potential participants Patients who have a contraindication to Dupixent according to the country-specific prescribing information Treatment with Dupixent within 6 months before the baseline visit. Note: for patients who have been treated previously with DUPIXENT a washout period of 6 months is required before Visit 1. Any condition that, in the opinion of the Investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from adequately completing the schedule of visits and assessments Patients currently participating in any interventional clinical trial which modifies patient care. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dupilumab SAR231893
Pharmaceutical form:solution Route of administration: subcutaneous Dose regimen:

Locations

Country Name City State
Argentina Investigational Site Number : 0320001 Ciudad Autonoma Bs As
Argentina Investigational Site Number : 0320008 Ciudad Autonoma Buenos Aires
Argentina Investigational Site Number : 0320005 La Plata Buenos Aires
Argentina Investigational Site Number : 0320009 San Miguel de Tucuman
Argentina Investigational Site Number : 0320004 Santa Fe
Argentina Investigational Site Number : 0320006 Villa Rosa Buenos Aires
Chile Investigational Site Number : 1520002 Quillota Valparaíso
Chile Investigational Site Number : 1520001 Santiago Reg Metropolitana De Santiago
Colombia Investigational Site Number : 1700009 Barranquilla
Colombia Investigational Site Number : 1700004 Bogota
Colombia Investigational Site Number : 1700003 Bucaramanga
Israel Investigational Site Number : 3760008 Ashdod
Israel Investigational Site Number : 3760004 Ashkelon
Israel Investigational Site Number : 3760003 Jerusalem
Israel Investigational Site Number : 3760005 Jerusalem
Israel Investigational Site Number : 3760001 Kfar Saba
Israel Investigational Site Number : 3760006 Rehovot
Israel Investigational Site Number : 3760007 Tel Aviv
Kuwait Investigational Site Number : 4140001 Kuwait
Lebanon Investigational Site Number : 4220003 Achrafieh
Lebanon Investigational Site Number : 4220001 Beirut
Lebanon Investigational Site Number : 4220002 Beirut
Mexico Investigational Site Number : 4840003 Durango
Qatar Investigational Site Number : 6340001 Doha
Russian Federation Investigational Site Number : 6430005 Chelyabinsk
Russian Federation Investigational Site Number : 6430004 Moscow
Russian Federation Investigational Site Number : 6430007 Moscow
Russian Federation Investigational Site Number : 6430006 Rostov-on-Don
Russian Federation Investigational Site Number : 6430008 Saratov
Russian Federation Investigational Site Number : 6430002 Stavropol
Saudi Arabia Investigational Site Number : 6820005 Jeddah
Saudi Arabia Investigational Site Number : 6820004 Makkah
Saudi Arabia Investigational Site Number : 6820001 Riyadh
Saudi Arabia Investigational Site Number : 6820002 Riyadh
Singapore Investigational Site Number : 7020001 Singapore
Singapore Investigational Site Number : 7020002 Singapore
United Arab Emirates Investigational Site Number : 7840006 Abu Dhabi
United Arab Emirates Investigational Site Number : 7840001 Dubai
United Arab Emirates Investigational Site Number : 7840007 Dubai
United Arab Emirates Investigational Site Number : 7840002 Sharjah
United Arab Emirates Investigational Site Number : 7840004 Sharjah

Sponsors (2)

Lead Sponsor Collaborator
Sanofi Regeneron Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Chile,  Colombia,  Israel,  Kuwait,  Lebanon,  Mexico,  Qatar,  Russian Federation,  Saudi Arabia,  Singapore,  United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Primary Baseline Characteristics: Socio-demographics At baseline
Primary Baseline Characteristics: Medical history Including asthma history and asthma treatment history. At baseline
Primary Baseline Characteristics: Disease characteristics At baseline
Primary Baseline Characteristics: Concomitant treatments for asthma At baseline
Secondary Dupixent and other asthma treatment use patterns 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. Baseline to Month 54
Secondary Lung function Pre and post bronchodilator (BD) forced expiratory volume in 1 second (FEV1) over time. Baseline to Month 54
Secondary Annualized exacerbation rate 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.
Baseline to Month 54
Secondary Patient reported outcomes For asthma and type 2 comorbidities over time. Baseline to Month 54
Secondary Healthcare Resource Utilization 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. Baseline to Month 54
Secondary Number of participants with adverse events (AE) and serious adverse events (SAE) Baseline to Month 54
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