A Study in Male and Female Adolescent Participants With Severe Uncontrolled Asthma Starting Treatment With Dupilumab Injection (Dupixent®) (PEDIASTHMA)
Study on Severe Asthma Characteristics and Management
Study Overview
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
Study Details
52 weeks
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Asthma
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Age: 12 years - 17 years
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Gender: All
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.
This study investigates the characteristics of adolescents with severe asthma. Asthma is a condition where the airways in the lungs become inflamed and narrow, making it difficult to breathe. The purpose of this study is to understand more about these patients and how their asthma is managed.
Participants will receive an investigational medication and the study will assess how well their asthma is controlled over a year. The study will also look at other health issues related to Type 2 inflammation and monitor the safety of the treatment.
- Who can participate: Adolescents aged 12 to 17 years, who have been prescribed an investigational medication for severe uncontrolled asthma, may be eligible to participate. Adults 18 years and older are not eligible.
- Study details: Participants will take an investigational medication for their asthma. They will attend regular assessments to evaluate how well their asthma is controlled. Safety will also be assessed during the treatment period.
- Study Timelines: The study will last 52 weeks.
