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

Airway Remodeling Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03842839
• Other study ID #: ESCOPD-20181001
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 2022

Study information

• Verified date: September 2022
• Source: Guangzhou Institute of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Key inclusion criteria

• Over 40 yrs; Male or female Diagnosed with COPD

• Pre-bronchodilator FEV1 =80% pred ;

• Patients must be able to perform all study related procedures

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.

Related Conditions & MeSH terms

• Airway Remodeling

Intervention

Drug:
• Tiotropium Inhalation Powder [Spiriva] 0.018mg
Tiotropium bromide (Spiriva) capsule 18µg once daily inhaled.
• Salbutamol sulphate aerosol (Ventolin) 0.01mg
As needed use of salbutamol sulphate aerosol (Ventolin) when exacerbation happens

Locations

Country	Name	City	State
China	Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change 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	Ai accessed by endobronchial optical coherence tomography will be obtained at baseline, month 24.
Primary	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	Ai accessed by endobronchial optical coherence tomography will be obtained at month 12.
Secondary	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	Aw% accessed by endobronchial optical coherence tomography will be obtained at baseline, month 12.
Secondary	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	Aw% accessed by endobronchial optical coherence tomography will be obtained at month24.
Secondary	Change from baseline in trough FEV1	To evaluate the effects of Tiotropium in improving lung function	Pulmonary function test will be performed at baseline, month 6, 12, 18 and 24.
Secondary	Change from baseline in resonant frequency (Fres) at month 6, 12, 18 and 24.	To evaluate the effects of Tiotropium in improving lung function	IOS will be performed at baseline, month 6, 12, 18 and 24.
Secondary	Change from baseline in peripheral airway resistance (R5-R20)	To evaluate the effects of Tiotropium in improving lung function	IOS will be performed at baseline, month 6, 12, 18 and 24.
Secondary	Total times of SABA usage	To evaluate the times of SABA administration	During the two years treatment period, times of SABA administration will be recored.
Secondary	Total dosage of SABA usage	To evaluate the dosage of SABA administration	During the two years treatment period, the dosage of SABA administration will be recored.