Effect of Tiotropium on Airway Remodeling in Patients With Early Stage COPD Accessed by Optical Coherence Tomography

Not Applicable

Recruiting

• Conditions: Airway Remodeling
• Interventions: Drug: Tiotropium Inhalation Powder [Spiriva] 0.018mg; Drug: Salbutamol sulphate aerosol (Ventolin) 0.01mg

• Registration Number: NCT03842839
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-15
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-29
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tiotropium (0-12 month) + SABA as needed	Tiotropium Inhalation Powder [Spiriva] 0.018mg	* 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.
Tiotropium (0-24 month) + SABA as needed	Tiotropium Inhalation Powder [Spiriva] 0.018mg	* 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.
Tiotropium (0-24 month) + SABA as needed	Salbutamol sulphate aerosol (Ventolin) 0.01mg	* 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.
SABA as needed only	Salbutamol sulphate aerosol (Ventolin) 0.01mg	* 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.
Tiotropium (0-12 month) + SABA as needed	Salbutamol sulphate aerosol (Ventolin) 0.01mg	* 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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the inner luminal area (Ai) of the 3th to 9th generation bronchi at month 12	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	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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in trough FEV1	Pulmonary function test will be performed at baseline, month 6, 12, 18 and 24.	To evaluate the effects of Tiotropium in improving lung function
Total times of SABA usage	During the two years treatment period, times of SABA administration will be recored.	To evaluate the times of SABA administration
Total dosage of SABA usage	During the two years treatment period, the dosage of SABA administration will be recored.	To evaluate the dosage of SABA administration
Change from baseline in peripheral airway resistance (R5-R20)	IOS will be performed at baseline, month 6, 12, 18 and 24.	To evaluate the effects of Tiotropium in improving lung function
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.	To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD
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.	To evaluate the effects of Tiotropium in improving lung function
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.	To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD

Trial Locations

Locations (1)

Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China