A Study in Male and Female Adolescent Participants With Severe Uncontrolled Asthma Starting Treatment With Dupilumab Injection (Dupixent®)

NCT05070663 | Completed

• 2 other identifiers: OBS17083U1111-1256-9593
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective: \- Describe the characteristics of enrolled severe asthma patients Secondary objectives:

• Assess the control of asthma under dupilumab (Dupixent®) treatment until 1 year
• Assess the clinical objectives of the asthma care
• Assess comorbidities associated with Type 2 inflammation
• Assess safety during the year of treatment

Conditions

Asthma

Outcome Measures

Primary Outcomes (5)

• Medical history (including history of asthma)

  Relevant medical history other than asthma according to the investigator (including documented comorbidities associated with type 2 inflammation). Asthma history includes patient age at the time of diagnosis and family history.

  At the start of treatment with Dupixent® (day 1)

• Previous treatments for asthma

  Background asthma treatments (doses and international nonproprietary name (INN) of inhaled corticosteroids (ICS), long-acting beta-2 agonist (LABA) and oral corticosteroids (OCS), etc) including cumulative yearly dose of OCS. Use of oral corticosteroids due to exacerbation of asthma (dose, INN). Use of emergency treatments (short-acting beta-2 agonist (SABA)) (number of times per week).

  At the start of treatment with Dupixent® (day 1)

• Demographic characteristics

  Age and gender.

  At the start of treatment with Dupixent® (day 1)

• Disease characteristics

  Disease characteristics at the inclusion including severity (Global Initiative for Asthma (GINA) step), number of severe exacerbations during the past year, number of days in intensive care unit (ICU) for severe exacerbation since the diagnosis, forced expiratory volume per second (FEV1), Asthma Control Test (ACT) score.

  At the start of treatment with Dupixent® (day 1)

• Concomitant medication

  Relevant concomitant medication other than medication for asthma according to the investigator.

  At the start of treatment with Dupixent® (day 1)

Secondary Outcomes (14)

• Change from baseline to week 52 in asthma control test (ACT) score at each subsequent visit over the year of treatment

  From baseline (day 1) to week 52

• Change from baseline to week 52 in number of annualized exacerbations and description of exacerbation setting

  From baseline (day 1) to week 52

• Change from baseline to week 52 in Paediatric Asthma Quality of Life Questionnaire (PAQLQ) score

  From baseline (day 1) to week 52

• Change from baseline to week 52 in corticosteroid dose

  From baseline (day 1) to week 52

• Change from baseline to week 52 in pre- bronchodilator forced expiratory volume per second (FEV1)

  From baseline (day 1) to week 52

Study Arms (1)

Participants with severe asthma

Adolescents, for whom initiation of dupilumab (Dupixent®) for the severe uncontrolled asthma indication was decided by the investigator before the inclusion in the study.

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Adolescents, for whom initiation of dupilumab (Dupixent®) for the severe uncontrolled asthma indication was decided by the investigator before the inclusion in the study.

You may qualify if:

• Adolescents ≥ 12 and \< 18 years of age at the time of the initiation of Dupixent® treatment

You may not qualify if:

• \- Adult participants ≥ 18 years of age
• The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational site France

France, France

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 52 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 7, 2021
• Study Start: November 4, 2021
• Primary Completion: March 14, 2024
• Study Completion: March 3, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)