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
52 weeks
Study Type
OBSERVATIONAL
Enrollment
105
Investigational site France
France, France
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.
Time frame: 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).
Time frame: At the start of treatment with Dupixent® (day 1)
Demographic characteristics
Age and gender.
Time frame: 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.
Time frame: At the start of treatment with Dupixent® (day 1)
Concomitant medication
Relevant concomitant medication other than medication for asthma according to the investigator.
Time frame: At the start of treatment with Dupixent® (day 1)
Change from baseline to week 52 in asthma control test (ACT) score at each subsequent visit over the year of treatment
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ACT score range: 5-25; higher score indicates better asthma control.
Time frame: From baseline (day 1) to week 52
Change from baseline to week 52 in number of annualized exacerbations and description of exacerbation setting
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.
Time frame: From baseline (day 1) to week 52
Change from baseline to week 52 in Paediatric Asthma Quality of Life Questionnaire (PAQLQ) score
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).
Time frame: From baseline (day 1) to week 52
Change from baseline to week 52 in corticosteroid dose
Change in corticosteroid dose.
Time frame: From baseline (day 1) to week 52
Change from baseline to week 52 in pre- bronchodilator forced expiratory volume per second (FEV1)
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time frame: From baseline (day 1) to week 52
Change from baseline to week 52 in number of food allergic reactions
Following food allergic reactions will be recorded: allergic symptoms and anaphylaxis in real life or during an oral food challenge.
Time frame: From baseline (day 1) to week 52
Change from baseline to week 52 in in visual analogue scale (VAS) score for allergic rhinitis
VAS score range: 0 ('no symptoms') to 100 ('severe symptoms').
Time frame: From baseline (day 1) to week 52
Change from baseline to week 52 in in Score for atopic dermatitis (SCORAD) score for atopic dermatitis
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.
Time frame: From baseline (day 1) to week 52
Change from baseline to week 52 in sinonasal symptoms of nasal polyposis of food allergies
Following sinonasal symptoms will be recorded: nasal congestion, loss in smell, posterior nasal discharge, anterior nasal discharge.
Time frame: From baseline (day 1) to week 52
Responder rates at week 52 for ACT (according to the minimal important difference (MID))
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.
Time frame: At week 52
Responder rates at week 52 for PAQLQ (according to the MID))
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).
Time frame: At week 52
Reasons for Dupixent® discontinuation
All reasons for treatment discontinuation.
Time frame: Day 1 to week 52
Collection of adverse events
Number of adverse events.
Time frame: Day 1 to week 52
Collection of serious adverse events
Number of serious adverse events.
Time frame: Day 1 to week 52