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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Tiotropium bromide (Spiriva) capsule 18μg once daily inhaled.
As needed use of salbutamol sulphate aerosol (Ventolin) when exacerbation happens
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGChange from baseline in the inner luminal area (Ai) of the 3th to 9th generation bronchi at month 24
To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD
Time frame: Ai accessed by endobronchial optical coherence tomography will be obtained at baseline, month 24.
Change from baseline in the inner luminal area (Ai) of the 3th to 9th generation bronchi at month 12
To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD
Time frame: Ai accessed by endobronchial optical coherence tomography will be obtained at month 12.
Change from baseline in the airway wall area percentage (Aw%) of the 3th to 9th generation bronchi at month 12
To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD
Time frame: Aw% accessed by endobronchial optical coherence tomography will be obtained at baseline, month 12.
Change from baseline in the airway wall area percentage (Aw%) of the 3th to 9th generation bronchi at month 24
To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD
Time frame: Aw% accessed by endobronchial optical coherence tomography will be obtained at month24.
Change from baseline in trough FEV1
To evaluate the effects of Tiotropium in improving lung function
Time frame: Pulmonary function test will be performed at baseline, month 6, 12, 18 and 24.
Change from baseline in resonant frequency (Fres) at month 6, 12, 18 and 24.
To evaluate the effects of Tiotropium in improving lung function
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Time frame: IOS will be performed at baseline, month 6, 12, 18 and 24.
Change from baseline in peripheral airway resistance (R5-R20)
To evaluate the effects of Tiotropium in improving lung function
Time frame: IOS will be performed at baseline, month 6, 12, 18 and 24.
Total times of SABA usage
To evaluate the times of SABA administration
Time frame: During the two years treatment period, times of SABA administration will be recored.
Total dosage of SABA usage
To evaluate the dosage of SABA administration
Time frame: During the two years treatment period, the dosage of SABA administration will be recored.