A Double-blind, Randomised, Cross-over, Multi-centre Study, to Evaluate Onset of Effect in the Morning in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort®Turbuhaler® 320/9 μg, Compared With Seretide® Diskus® 50/500 μg, Both Given as One Inhalation Twice Daily for One Week Each.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 442
- 试验地点
- 1
- 主要终点
- Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose
研究概览
简要总结
This study is to assess the effects with two different inhaled respiratory medications with regards to improvement of lung function, symptoms and morning activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient, female or male aged ≥40 years, diagnosis of COPD with symptoms for at least 2 years
- •FEV1 ≤50% of predicted normal value, pre-bronchodilator, FEV1/VC <70%
- •Pre-bronchodilator
排除标准
- •Current respiratory tract disorder other than COPD
- •History of asthma or rhinitis
- •Significant or unstable cardiovascular disorder
研究组 & 干预措施
Symbicort Turbuhaler First, then Seretide Diskus
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
干预措施: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg (Drug)
Symbicort Turbuhaler First, then Seretide Diskus
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
干预措施: Seretide Diskus (salmeterol/fluticasone) 50/500 μg (Drug)
Seretide Diskus First, then Symbicort Turbuhaler
Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
干预措施: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg (Drug)
Seretide Diskus First, then Symbicort Turbuhaler
Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
干预措施: Seretide Diskus (salmeterol/fluticasone) 50/500 μg (Drug)
结局指标
主要结局
Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose
时间窗: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
The change from baseline in PEF was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and all days of treatment, with baseline as covariate.
次要结局
- PEF Before Morning Dose(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
- PEF 15 Minutes After Morning Dose(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
- PEF Before Evening Dose(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
- Forced Expiratory Volume in 1 Second (FEV1) Before Morning Dose(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
- FEV1 15 Minutes After Morning Dose(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
- FEV1 Before Evening Dose(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
- Change in PEF From Before Dose to 5 Minutes After Dose in the Morning(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
- Change in PEF From Before Dose to 15 Minutes After Dose in the Morning(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
- Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
- Change in FEV1 From Before Dose to 15 Minutes After Dose in the Morning(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
- Change in FEV1 From Before Dose to 5 Minutes After Dose at the Clinic(Baseline (run-in, and washout) and day 1 of treatment period)
- Change in Forced Vital Capacity (FVC) From Before Dose to5 Minutes After Dose at the Clinic(Baseline (run-in, and washout) and day 1 of treatment period)
- Capacity of Daily Living in the Morning (CDLM) (Change From Pre to End of Treatment)(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
- Difficulty in Getting Out From Bed (MASQ) (Change From Pre to End of Treatment)(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)
- The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change From Pre to End of Treatment)(Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days)