NCT01069289已完成3 期
A Phase III, 12-week, Double-blind, Randomised, Parallel-group, Active-controlled, Multinational, Efficacy and Safety Study of Symbicort® Turbuhaler® 160/4.5 μg 2 Inhalations Twice Daily (Bid) Compared to Oxis® Turbuhaler® 4.5 μg 2 Inhalations Twice Daily (Bid) in Patients With Chronic Obstructive Pulmonary Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,293
- 试验地点
- 2
- 主要终点
- Pre-dose Forced Expiratory Volume in One Second (FEV1)
研究概览
简要总结
The primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in patients with COPD.
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
- 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
- •A current clinical diagnosis of Chronic Obstructive Pulmonary Disease
- •Documented Chronic Obstructive Pulmonary Disease symptoms for more than 2 years
- •A smoking history of at least 10 pack years
排除标准
- •History and/or current clinical diagnosis of asthma
- •History and/or current clinical diagnosis of atopic diseases such as allergic rhinitis
研究组 & 干预措施
1
Experimental
Symbicort Turbuhaler 160/4.5 microgram, 2 inhalations twice daily
干预措施: Budesonide/formoterol (Symbicort Turbuhaler) (Drug)
2
Active Comparator
Oxis Turbuhaler 4.5 microgram, 2 inhalations twice daily
干预措施: Formoterol (Oxis Turbuhaler) (Drug)
结局指标
主要结局
Pre-dose Forced Expiratory Volume in One Second (FEV1)
时间窗: Before randomization, 0, 4, 8 and 12 weeks after randomization
The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
次要结局
- 1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1)(Before randomization, 0, 4, 8 and 12 weeks after randomization)
- Pre-dose Forced Vital Capacity (FVC)(Before randomization, 0, 4, 8 and 12 weeks after randomization)
- 1 Hour Post-dose Forced Vital Capacity (FVC)(Before randomization, 0, 4, 8 and 12 weeks after randomization)
- Percentage of Participants With Exacerbations(Daily during 12-week randomization treatment)
- Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation(Daily during 12-week randomization treatment)
- Morning Peak Expiratory Flow(PEF)(Daily during run-in period and daily during 12-week randomization treatment)
- Evening Peak Expiratory Flow (PEF)(Daily during run-in period and daily during 12-week randomization treatment)
- Total Number of Day With Exacerbation(Daily during 12-week randomization treatment)
- Morning Forced Expiratory Volume in One Second (FEV1)(Daily during run-in period and daily during 12-week randomization treatment)
- Evening Forced Expiratory Volume in One Second (FEV1)(Daily during run-in period and daily during 12-week randomization treatment)
- Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms(Daily during run-in period and daily during 12-week randomization treatment)
- Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms(Daily during run-in period and daily during 12-week randomization treatment)
- Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms(Daily during run-in period and daily during 12-week randomization treatment)
- Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score(Daily during run-in period and daily during 12-week randomization treatment)
- Use of Rescue Medication(Daily during run-in period and daily during 12-week randomization treatment)
- St George's Respiratory Questionnaire (SGRQ) Total Score(Daily during run-in period and daily during 12-week randomization treatment)
研究者
研究点 (2)
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