NCT06018441已完成不适用
National, Multicenter, Non-interventional, Prospective Study to Explore the Quality of Life of Patients With Severe Asthma Starting Treatment With Dupilumab (Dupixent®) in a Real-world Setting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Change from baseline in health-related quality of life (HRQoL), as measured by the St. George's Respiratory Questionnaire (SGRQ)
研究概览
简要总结
Primary Objective:
- To describe dupilumab health-related quality of life (HRQoL) effectiveness at 52 weeks compared to baseline.
Secondary Objectives:
- To describe dupilumab HRQoL effectiveness at 12 and 24 weeks compared to baseline.
- To assess the safety during the year of treatment in a real-world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.
- •Participant for whom decision of initiation and prescription of dupilumab (Dupixent®) for the severe uncontrolled asthma indication was made by the investigator within four weeks before the inclusion in the study. Oral CorticoSteroid (OCS) or non-OCS-dependent patient could be included.
- •Participant for whom St. George's Respiratory Questionnaire (SGRQ) score is available within the last 4 weeks prior to dupilumab initiation. SGRQ score could be collected at baseline visit for participants who have not yet started dupilumab.
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Participant below 18 years of age. - Participant participating in a clinical trial at the time of enrolment.
- •Participant under guardianship, trusteeship or under judicial protection.
- •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
Change from baseline in health-related quality of life (HRQoL), as measured by the St. George's Respiratory Questionnaire (SGRQ)
时间窗: Baseline (Day 0), Week 52
The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.
次要结局
- Number of participants with adverse events (AEs)(Day 0 to Week 52)
- Change from baseline in health-related quality of life (HRQoL), as measured by the St. George's Respiratory Questionnaire (SGRQ)(Baseline (Day 0), Week 12 and Week 24)
- Number of participants with medication errors(Day 0 to Week 52)
- Number of participants with serious adverse events (SAEs)(Day 0 to Week 52)
- Number of participants with adverse events of special interest(Day 0 to Week 52)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis PatientsAtopic Dermatitis EczemaAtopic DermatitisNCT03667014University of California, San Francisco34
已完成
3 期
Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up)AsthmaNCT03620747Sanofi393
已完成
不适用
Real Life Experience Survey of Dupilumab in the NetherlandsSevere AsthmaNCT05331755Gert-Jan Braunstahl120
已完成
3 期
A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal PolypsChronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)NCT02912468Sanofi276
已完成
4 期
A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community SettingPsoriasisNCT05701995Bristol-Myers Squibb180