A Multi-centre, Randomised, Double-blind, Cross-over Design Study to Evaluate Efficacy on Exercise Tolerance of Symbicort ®(Budesonide/Formoterol) 320/9μg One Inhalation Twice Daily Compared With Placebo and Oxis® 9μg One Inhalation Twice Daily in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose
研究概览
简要总结
The purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •>=40 years of age
- •diagnosed COPD with symptoms >= 2 years
- •pre-bronchodilatory FEV1 <=50% of PN
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 then Formoterol then Placebo
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
干预措施: budesonide/formoterol Turbuhaler 320/9µg (Drug)
Symbicort then Formoterol then Placebo
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
干预措施: formoterol Turbuhaler 9µg (Drug)
Symbicort then Formoterol then Placebo
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
干预措施: Placebo (Other)
Formoterol then Symbicort then Placebo
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
干预措施: budesonide/formoterol Turbuhaler 320/9µg (Drug)
Formoterol then Symbicort then Placebo
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
干预措施: formoterol Turbuhaler 9µg (Drug)
Formoterol then Symbicort then Placebo
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
干预措施: Placebo (Other)
Placebo then Formoterol then Symbicort
Placebo, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
干预措施: budesonide/formoterol Turbuhaler 320/9µg (Drug)
Placebo then Formoterol then Symbicort
Placebo, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
干预措施: formoterol Turbuhaler 9µg (Drug)
Placebo then Formoterol then Symbicort
Placebo, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
干预措施: Placebo (Other)
结局指标
主要结局
Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose
时间窗: Single measurement taken1 hour post-dose at the end of each 1-week treatment period
Treatment means from individual patient data. Patients with only one EET value where excluded since this model, with patient and period as fixed factors, required data from at least two periods.
次要结局
- Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose(Single measurement taken 6 hours post-dose at the end of each 1-week treatment period)
- Forced Expiratory Flow (FEV1) Pre-dose(Pre-dose at the start of treatment and pre-dose after one week of treatment)
- Forced Vital Capacity (FVC) Pre-dose(Pre-dose at the start of treatment and pre-dose after one week of treatment)
- Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment)(Pre-dose at the start of treatment and pre-dose after one week of treatment)
- Peak Expiratory Flow (PEF) Before Morning Dose(Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period)
- Sleep Score(Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period)
- Breathlessness Score(Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period)
- Chest Tightness Score(Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period)
- Cough Score(Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period)
- Number of Inhalations of Reliever Medication(Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period)
- Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose(Single measurement performed at rest prior to exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period)
- Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose(Single measurement performed after exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period)
- Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose(Single measurement performed at rest prior to exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period)
- Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose(Single measurement performed after exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period)
- Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose(Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period)
- Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose(Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period)
- Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)(Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period)
- Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)(Single measurement obtained before exercise endurance test performed 1hour post-dose at the end of each 1-week treatment period)
- Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)(Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period)
- Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)(Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period)
- Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)(Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period)
- Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)(Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period)
- Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET)(Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period)
- Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)(Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period)
- Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)(Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period)
- Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)(Single measurement obtained before exercise endurance test performed 6 hous post-dose at the end of each 1-week treatment period)
- Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)(Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period)
- Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET(Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period)
- SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score(Single measurement taken at the end of each 1-week treatment period)