Clinical trial NCT05070663: A Study in Male and Female Adolescent Participants With Severe Uncontrolled Asthma Starting Treatment With Dupilumab Injection (Dupixent®)
Official title: National, Multicentre, Non-interventional, Prospective and Retrospective Study in Adolescent Patients With Severe Uncontrolled Asthma Starting Treatment With Dupilumab (Dupixent®)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2021-10-07
Enrollment: 105
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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

Detailed description: 52 weeks

Eligibility criteria: 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.

Primary outcomes:
measure: Medical history (including history of asthma)
timeFrame: At the start of treatment with Dupixent® (day 1)
measure: Previous treatments for asthma
timeFrame: At the start of treatment with Dupixent® (day 1)
measure: Demographic characteristics
timeFrame: At the start of treatment with Dupixent® (day 1)
measure: Disease characteristics
timeFrame: At the start of treatment with Dupixent® (day 1)
measure: Concomitant medication
timeFrame: At the start of treatment with Dupixent® (day 1)
Secondary outcomes:
measure: Change from baseline to week 52 in asthma control test (ACT) score at each subsequent visit over the year of treatment
timeFrame: From baseline (day 1) to week 52
measure: Change from baseline to week 52 in number of annualized exacerbations and description of exacerbation setting
timeFrame: From baseline (day 1) to week 52
measure: Change from baseline to week 52 in Paediatric Asthma Quality of Life Questionnaire (PAQLQ) score
timeFrame: From baseline (day 1) to week 52
measure: Change from baseline to week 52 in corticosteroid dose
timeFrame: From baseline (day 1) to week 52
measure: Change from baseline to week 52 in pre- bronchodilator forced expiratory volume per second (FEV1)
timeFrame: From baseline (day 1) to week 52
measure: Change from baseline to week 52 in number of food allergic reactions
timeFrame: From baseline (day 1) to week 52
measure: Change from baseline to week 52 in in visual analogue scale (VAS) score for allergic rhinitis
timeFrame: From baseline (day 1) to week 52
measure: Change from baseline to week 52 in in Score for atopic dermatitis (SCORAD) score for atopic dermatitis
timeFrame: From baseline (day 1) to week 52
measure: Change from baseline to week 52 in sinonasal symptoms of nasal polyposis of food allergies
timeFrame: From baseline (day 1) to week 52
measure: Responder rates at week 52 for ACT (according to the minimal important difference (MID))
timeFrame: At week 52
measure: Responder rates at week 52 for PAQLQ (according to the MID))
timeFrame: At week 52
measure: Reasons for Dupixent® discontinuation
timeFrame: Day 1 to week 52
measure: Collection of adverse events
timeFrame: Day 1 to week 52
measure: Collection of serious adverse events
timeFrame: Day 1 to week 52
Other outcomes:
Locations:
city: France
country: France
facility: Investigational site France
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: