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

Sanofi

Status: Completed

Conditions: Asthma

Study type: Observational

Funder types: Industry

Identifiers

NCT05070663

U1111-1256-9593 (Registry Identifier)

OBS17083

Details and patient eligibility

About

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

Full description

52 weeks

Enrollment: 105 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adolescents, for whom initiation of dupilumab (Dupixent®) for the severe uncontrolled asthma indication was decided by the investigator before the inclusion in the study
• Adolescents ≥ 12 and < 18 years of age at the time of the initiation of Dupixent® treatment

Exclusion criteria

• 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.

Trial design

105 participants in 1 patient group

Participants with severe asthma

Description:

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