Effect of Tiotropium on Airway Remodeling in Patients With Early Stage COPD Accessed by Optical Coherence Tomography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline in the inner luminal area (Ai) of the 3th to 9th generation bronchi at month 12
研究概览
简要总结
The study aims to explore the effect of tiotropium on airway remodeling by using Endobronchial Optical Coherence Tomography (EB-OCT). We enrolled patients with GOLD I stage COPD. All the patients will be divided into four groups randomly to receive SABA as needed with or without regular use of tiotropium. Changes of airway morphology (accessed by EB-OCT), pulmonary function, QOL, and SABA usage will be obtained.
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
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients with other lung diseases (such as bronchiectasis, pneumothorax, pleural effusion, airway deformation, lung surgery, etc.).
- •Patients have poor compliance and are unwilling to receive medication regularly.
- •Other complications of bronchoscopy or intolerance of bronchoscopy procedure.
研究组 & 干预措施
Tiotropium (0-12 month) + SABA as needed
- During the 2 years treatment phase patients will be administered with tiotropium bromide (Spiriva) capsule 18μg once daily from baseline to the 12th months.
- Any long acting bronchodilator will not be used from the 12 to 24 months.
- Salbutamol sulphate aerosol (Ventolin) will be administered as concomitant medication treatment when exacerbation occurs.
干预措施: Tiotropium Inhalation Powder [Spiriva] 0.018mg (Drug)
Tiotropium (0-12 month) + SABA as needed
- During the 2 years treatment phase patients will be administered with tiotropium bromide (Spiriva) capsule 18μg once daily from baseline to the 12th months.
- Any long acting bronchodilator will not be used from the 12 to 24 months.
- Salbutamol sulphate aerosol (Ventolin) will be administered as concomitant medication treatment when exacerbation occurs.
干预措施: Salbutamol sulphate aerosol (Ventolin) 0.01mg (Drug)
Tiotropium (0-24 month) + SABA as needed
- During the 2 years treatment phase patients will be administered with tiotropium bromide (Spiriva) capsule 18μg once daily from baseline to the 24th months.
- Salbutamol sulphate aerosol (Ventolin) will be administered as concomitant medication treatment when exacerbation occurs.
干预措施: Tiotropium Inhalation Powder [Spiriva] 0.018mg (Drug)
Tiotropium (0-24 month) + SABA as needed
- During the 2 years treatment phase patients will be administered with tiotropium bromide (Spiriva) capsule 18μg once daily from baseline to the 24th months.
- Salbutamol sulphate aerosol (Ventolin) will be administered as concomitant medication treatment when exacerbation occurs.
干预措施: Salbutamol sulphate aerosol (Ventolin) 0.01mg (Drug)
SABA as needed only
- During the 2 years treatment phase patients will be administered with salbutamol sulphate aerosol (Ventolin) when exacerbation occurs.
- Any long acting bronchodilator will not be used during the 2 years treatment phase.
干预措施: Salbutamol sulphate aerosol (Ventolin) 0.01mg (Drug)
结局指标
主要结局
Change from baseline in the inner luminal area (Ai) of the 3th to 9th generation bronchi at month 12
时间窗: Ai accessed by endobronchial optical coherence tomography will be obtained at month 12.
To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD
Change from baseline in the inner luminal area (Ai) of the 3th to 9th generation bronchi at month 24
时间窗: Ai accessed by endobronchial optical coherence tomography will be obtained at baseline, month 24.
To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD
次要结局
- Change from baseline in trough FEV1(Pulmonary function test will be performed at baseline, month 6, 12, 18 and 24.)
- Total times of SABA usage(During the two years treatment period, times of SABA administration will be recored.)
- Total dosage of SABA usage(During the two years treatment period, the dosage of SABA administration will be recored.)
- Change from baseline in peripheral airway resistance (R5-R20)(IOS will be performed at baseline, month 6, 12, 18 and 24.)
- Change from baseline in the airway wall area percentage (Aw%) of the 3th to 9th generation bronchi at month 24(Aw% accessed by endobronchial optical coherence tomography will be obtained at month24.)
- Change from baseline in resonant frequency (Fres) at month 6, 12, 18 and 24.(IOS will be performed at baseline, month 6, 12, 18 and 24.)
- Change from baseline in the airway wall area percentage (Aw%) of the 3th to 9th generation bronchi at month 12(Aw% accessed by endobronchial optical coherence tomography will be obtained at baseline, month 12.)
研究者
ShiYue Li
Professor
Guangzhou Institute of Respiratory Disease