Description of Characteristics, Such as Age, Previous and Concurrent Treatments, Associated Diseases, of Patients With Asthma Treated With Dupilumab (DUPIXENT)

NCT ID: NCT04550962

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

376 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-02

Study Completion Date

2026-07-01

Brief Summary

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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

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Each patient will be followed during 36 months.

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with asthma

Eligible participants are initiating treatment with Dupixent for asthma according to the prescribing information in effect in each country

Dupilumab SAR231893

Intervention Type DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

Dose regimen:

Interventions

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Dupilumab SAR231893

Pharmaceutical form:solution Route of administration: subcutaneous

Dose regimen:

Intervention Type DRUG

Other Intervention Names

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Dupixent

Eligibility Criteria

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Exclusion Criteria

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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number : 0320005

La Plata, Buenos Aires, Argentina

Site Status

Investigational Site Number : 0320006

Villa Rosa, Buenos Aires, Argentina

Site Status

Investigational Site Number : 0320001

Ciudad Autonoma Bs As, , Argentina

Site Status

Investigational Site Number : 0320008

Ciudad Autonoma Buenos Aires, , Argentina

Site Status

Investigational Site Number : 0320009

San Miguel de Tucumán, , Argentina

Site Status

Investigational Site Number : 0320004

Santa Fe, , Argentina

Site Status

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, Chile

Site Status

Investigational Site Number : 1520002

Quillota, Región de Valparaíso, Chile

Site Status

Investigational Site Number : 1700009

Barranquilla, , Colombia

Site Status

Investigational Site Number : 1700004

Bogotá, , Colombia

Site Status

Investigational Site Number : 1700003

Bucaramanga, , Colombia

Site Status

Investigational Site Number : 3760008

Ashdod, , Israel

Site Status

Investigational Site Number : 3760004

Ashkelon, , Israel

Site Status

Investigational Site Number : 3760005

Jerusalem, , Israel

Site Status

Investigational Site Number : 3760003

Jerusalem, , Israel

Site Status

Investigational Site Number : 3760001

Kfar Saba, , Israel

Site Status

Investigational Site Number : 3760006

Rehovot, , Israel

Site Status

Investigational Site Number : 3760007

Tel Aviv, , Israel

Site Status

Investigational Site Number : 4140001

Kuwait City, , Kuwait

Site Status

Investigational Site Number : 4220002

Beirut, , Lebanon

Site Status

Investigational Site Number : 4220001

Beirut, , Lebanon

Site Status

Investigational Site Number : 4220003

El Achrafiyé, , Lebanon

Site Status

Investigational Site Number : 4840003

Durango, , Mexico

Site Status

Investigational Site Number : 6340001

Doha, , Qatar

Site Status

Investigational Site Number : 6430005

Chelyabinsk, , Russia

Site Status

Investigational Site Number : 6430007

Moscow, , Russia

Site Status

Investigational Site Number : 6430004

Moscow, , Russia

Site Status

Investigational Site Number : 6430006

Rostov-on-Don, , Russia

Site Status

Investigational Site Number : 6430008

Saratov, , Russia

Site Status

Investigational Site Number : 6430002

Stavropol, , Russia

Site Status

Investigational Site Number : 6820005

Jeddah, , Saudi Arabia

Site Status

Investigational Site Number : 6820004

Mecca, , Saudi Arabia

Site Status

Investigational Site Number : 6820002

Riyadh, , Saudi Arabia

Site Status

Investigational Site Number : 6820001

Riyadh, , Saudi Arabia

Site Status

Investigational Site Number : 7020002

Singapore, , Singapore

Site Status

Investigational Site Number : 7020001

Singapore, , Singapore

Site Status

Investigational Site Number : 7840006

Abu Dhabi, , United Arab Emirates

Site Status

Investigational Site Number : 7840007

Dubai, , United Arab Emirates

Site Status

Investigational Site Number : 7840001

Dubai, , United Arab Emirates

Site Status

Investigational Site Number : 7840004

Sharjah city, , United Arab Emirates

Site Status

Investigational Site Number : 7840002

Sharjah city, , United Arab Emirates

Site Status

Countries

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Argentina Chile Colombia Israel Kuwait Lebanon Mexico Qatar Russia Saudi Arabia Singapore United Arab Emirates

Other Identifiers

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OBS16688

Identifier Type: -

Identifier Source: org_study_id

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