National, Multicentre, Non-interventional, Prospective and Retrospective Study in Adolescent Patients With Severe Uncontrolled Asthma Starting Treatment With Dupilumab (Dupixent®)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Medical history (including history of asthma)
研究概览
简要总结
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
详细描述
52 weeks
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- 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.
结局指标
主要结局
Medical history (including history of asthma)
时间窗: 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
时间窗: 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
时间窗: At the start of treatment with Dupixent® (day 1)
Relevant concomitant medication other than medication for asthma according to the investigator.
Demographic characteristics
时间窗: At the start of treatment with Dupixent® (day 1)
Age and gender.
Disease characteristics
时间窗: 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.
次要结局
- Change from baseline to week 52 in in Score for atopic dermatitis (SCORAD) score for atopic dermatitis(From baseline (day 1) to week 52)
- Change from baseline to week 52 in corticosteroid dose(From baseline (day 1) to week 52)
- Change from baseline to week 52 in pre- bronchodilator forced expiratory volume per second (FEV1)(From baseline (day 1) to week 52)
- Change from baseline to week 52 in sinonasal symptoms of nasal polyposis of food allergies(From baseline (day 1) to week 52)
- Collection of adverse events(Day 1 to week 52)
- 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)
- Change from baseline to week 52 in number of food allergic reactions(From baseline (day 1) to week 52)
- Change from baseline to week 52 in in visual analogue scale (VAS) score for allergic rhinitis(From baseline (day 1) to week 52)
- Collection of serious adverse events(Day 1 to week 52)
- Change from baseline to week 52 in number of annualized exacerbations and description of exacerbation setting(From baseline (day 1) to week 52)
- Responder rates at week 52 for ACT (according to the minimal important difference (MID))(At week 52)
- Reasons for Dupixent® discontinuation(Day 1 to week 52)
- Change from baseline to week 52 in Paediatric Asthma Quality of Life Questionnaire (PAQLQ) score(From baseline (day 1) to week 52)
- Responder rates at week 52 for PAQLQ (according to the MID))(At week 52)