NCT01054170已完成2 期
A 12-week, Phase II, Double-blind, Placebo-Controlled, Randomised, Parallel-Group, Multi-Centre Study to Assess the Effect of 60mg AZD9668 Administered Orally Twice Daily on Structural Changes in the Airways by Multi-Slice Computed Tomography in Patients With Chronic Obstructive Pulmonary Disease.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm)
研究概览
简要总结
The primary objective of the study is to evaluate structural changes effected by AD9668 in the airways of adults with Chronic Obstructive Pulmonary Disease (COPD) by Multi-Slice Computed Tomography (MSCT)
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD with symptoms over 1 year
- •FEV1/FVC < 70% and FEV1 >= 40 and < =70 % of predicted post-bronchodilator
- •Ex-smokers for at least 12 months
排除标准
- •Past history or current evidence of clinically significant heart disease
- •Current diagnosis of asthma
- •Worsening of COPD requiring hospitalisation and/or treatment with antibiotics and/or an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b
研究组 & 干预措施
AZD9668
Experimental
干预措施: AZD9668 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm)
时间窗: Measured after 12 weeks treatment (day 84)
AWT-Pi10 (mm) as a measure of structural changes in airways. End of treatment Least Squares Mean.
次要结局
- 5th Generation Wall Area Percentage(Measured after 12 weeks treatment (day 84))
- Air Trapping Index (ATI) on Expiratory Scans(Measured after 12 weeks treatment (day 84))
- Pre-bronchodilator Inspiratory Capacity (IC)(Measured after 12 weeks treatment (day 84))
- Pre-bronchodilator Total Lung Capacity (TLC)(Measured after 12 weeks treatment (day 84))
- Pre-bronchodilator Functional Residual Capacity (FRC)(Measured after 12 weeks treatment (day 84))
- Pre-bronchodilator Residual Volume (RV)(Measured after 12 weeks treatment (day 84))
- Pre-bronchodilator Specific Airway Conductance (SGaw)(Measured after 12 weeks treatment (day 84))
- Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco)(Measured after 12 weeks treatment (day 84))
- Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)(Measured after 12 weeks treatment (day 84))
- Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)(Measured after 12 weeks treatment (day 84))
- Pre-bronchodilator Forced Vital Capacity (FVC)(Measured after 12 weeks treatment (day 84))
- Post-bronchodilator Forced Vital Capacity (FVC)(Measured after 12 weeks treatment (day 84))
- Pre-bronchodilator Slow Vital Capacity (SVC)(Measured after 12 weeks treatment (day 84))
- Post-bronchodilator Slow Vital Capacity (SVC)(Measured after 12 weeks treatment (day 84))
- Peak Expiratory Flow (PEF) Morning (Daily Recordings)(Average from measurements recorded daily by patient in last 6 weeks of treatment.)
- Peak Expiratory Flow (PEF) Evening (Daily Recordings)(Average from measurements recorded daily by patient in last 6 weeks of treatment.)
- Forced Expiratory Volume in 1 Second (FEV1) Morning (Daily Recordings)(Average from measurements recorded daily by patient in last 6 weeks of treatment.)
- Forced Expiratory Volume in 1 Second (FEV1) Evening (Daily Recordings)(Average from measurements recorded daily by patient in last 6 weeks of treatment.)
- Breathlessness, Cough and Sputum Scale (BCSS) Total Score(Average from measurements recorded daily by patient in last 6 weeks of treatment.)
- EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score(Average from measurements recorded daily by patient in last 6 weeks of treatment.)
- St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score(Measured after 12 weeks treatment (day 84))
- Percentage of Reliever Free Days in Last Six Weeks of Treatment(Average from measurements recorded daily by patient in last 6 weeks of treatment.)
- Exacerbations(Exacerbations were recorded at all study visits (after 1, 4, 8, and 12 weeks of treatment and at follow up))
研究者
研究点 (1)
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