A Study in Male and Female Adolescent Participants With Severe Uncontrolled Asthma Starting Treatment With Dupilumab Injection (Dupixent®)
- Conditions
- Asthma
- Registration Number
- NCT05070663
- Lead Sponsor
- Sanofi
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Medical history (including history of asthma) At the start of treatment with Dupixent® (day 1) 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.
Previous treatments for asthma At the start of treatment with Dupixent® (day 1) 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).
Concomitant medication At the start of treatment with Dupixent® (day 1) Relevant concomitant medication other than medication for asthma according to the investigator.
Demographic characteristics At the start of treatment with Dupixent® (day 1) Age and gender.
Disease characteristics At the start of treatment with Dupixent® (day 1) 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.
- Secondary Outcome Measures
Name Time Method Change from baseline to week 52 in in Score for atopic dermatitis (SCORAD) score for atopic dermatitis From baseline (day 1) to week 52 SCORAD is a clinical tool for assessing the severity (i.e., extent, intensity) of atopic dermatitis as objectively as possible with scores ranging from 0-100. The higher the score indicates more severe atopic dermatitis.
Change from baseline to week 52 in corticosteroid dose From baseline (day 1) to week 52 Change in corticosteroid dose.
Change from baseline to week 52 in pre- bronchodilator forced expiratory volume per second (FEV1) From baseline (day 1) to week 52 FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Change from baseline to week 52 in sinonasal symptoms of nasal polyposis of food allergies From baseline (day 1) to week 52 Following sinonasal symptoms will be recorded: nasal congestion, loss in smell, posterior nasal discharge, anterior nasal discharge.
Collection of adverse events Day 1 to week 52 Number of adverse events.
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 ACT score range: 5-25; higher score indicates better asthma control.
Change from baseline to week 52 in number of food allergic reactions From baseline (day 1) to week 52 Following food allergic reactions will be recorded: allergic symptoms and anaphylaxis in real life or during an oral food challenge.
Change from baseline to week 52 in in visual analogue scale (VAS) score for allergic rhinitis From baseline (day 1) to week 52 VAS score range: 0 ('no symptoms') to 100 ('severe symptoms').
Collection of serious adverse events Day 1 to week 52 Number of serious adverse events.
Change from baseline to week 52 in number of annualized exacerbations and description of exacerbation setting From baseline (day 1) to week 52 An exacerbation is defined as deterioration of asthma requiring use of systemic corticosteroids for ≥3 days; or increase in oral corticosteroids (OCS) dose at ≥2 times the current dose for ≥3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.
Responder rates at week 52 for ACT (according to the minimal important difference (MID)) At week 52 A participant is defined as responder if he/she has a change from baseline of 3 points or more at week 52 on the ACT score. ACT score range: 5-25; higher score indicates better asthma control.
Reasons for Dupixent® discontinuation Day 1 to week 52 All reasons for treatment discontinuation.
Change from baseline to week 52 in Paediatric Asthma Quality of Life Questionnaire (PAQLQ) score From baseline (day 1) to week 52 Questionnaire including 23 questions in 3 domains (symptoms, activity limitation, emotional function) and a 7-point scale (7 = not bothered at all; 1 = extremely bothered).
Responder rates at week 52 for PAQLQ (according to the MID)) At week 52 A participant is defined as responder if he/she has a change from baseline of 0.5 points or more at week 52 on the PAQLQ score. The PAQLQ(S) overall score is calculated by adding points of individual responses to all questions, with the higher scores indicating less impairment that is, a better quality of life. Questionnaire including 23 questions in 3 domains (symptoms, activity limitation, emotional function) and a 7-point scale (7 = not bothered at all; 1 = extremely bothered).
Trial Locations
- Locations (1)
Investigational site France
🇫🇷France, France