Seretide 100 DK vs Flixotide 100 DK in IMT in Moderate Asthma in Adults on Static Lung Volumes (Mechanistic Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 81
- 主要终点
- Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Over Weeks 5-12
研究概览
简要总结
This study will compare during 12 weeks, two treatment strategies for Initial Maintenance Therapy : fluticasone propionate alone or the salmeterol/fluticasone propionate combination in adults with moderate persistent asthma
详细描述
A multicentre randomised, double-blind, parallel-group study to compare the salmeterol/fluticasone propionate combination (SERETIDETM DISKUSTM 50/100) 50/100µg one inhalation twice daily with fluticasone propionate (FLIXOTIDETM DISKUSTM 100) 100µg one inhalation twice daily as initial maintenance therapy for 12 weeks in adults with persistent moderate asthma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female ≥ 18
- •documented history of asthma
- •reversibility FEV1 or PEF ≥ 12% (post 400µg salbu)
- •moderate asthma (daily symptoms, daily rescue use, PEF = 60-80% predicted value)
- •naive or ≥ 4weeks-free ICS (inhaled corticosteroids)
排除标准
- •respiratory disorder
- •FEV1<60% predicted
- •exacerbation/respiratory infection ≤ 4 weeks
- •oral/parenteral/depot corticosteroids ≤ 6 months
- •LABA/oral β2 agonist/ ALT/ theophylline ≤ 4 weeks
- •smoker or former smoker ≥ 5 packs year
结局指标
主要结局
Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Over Weeks 5-12
时间窗: Baseline, Weeks 5-12
Mini Wright Peak Flow Meter used to allow patients to monitor their asthma - Peak Flow (or PEF - peak expiratory flow) is a measurement of how fast you can blow out. When someone is well, their PEF is higher - when the airways are narrow (as in asthma), PEF is lower. Readings based on age, height and gender.
次要结局
- Change From Baseline in Pre-dose FEV1 (Forced Expiratory Volume in One Second) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)(Baseline through Week 12)
- Change From Baseline in Pre-dose (Percent Predicted) FEV1 Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)(Baseline through Week 12)
- Change From Baseline in FEV1 Reversibility Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)(Baseline through Week 12)
- Change From Baseline in Pre-dose Forced Expiratory Vital Capacity (FVC) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)(Baseline through Week 12)
- Change From Baseline (BL) in Pre-dose FEF 25-75% (Forced Expiratory Flow) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)(Baseline through Week 12)
- Number of Participants With at Least One Exacerbation During 12-Week Treatment Period(12-Week Treatment Period (Week 1 through Week 12))
- Number of Participants Who Achieved Well-Controlled Asthma During Weeks 5-12(Weeks 5 -12)
- Median Number of Weeks to First Achieve Well-Controlled Asthma During Weeks 5-12(Weeks 5 - 12)
- Number of Participants Who Achieved Total-controlled Asthma During Weeks 5-12(Weeks 5 - 12)
- Change From Baseline in Asthma Control Test (ACT) Score at Week 12(Baseline, Week 12)
- ACT Score in Classes at Week 12(Week 12)
- Change From Baseline in Overall Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12(Baseline, Week 12)