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

September 27, 2022 updated by: ShiYue Li, Guangzhou Institute of Respiratory Disease
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Tiotropium Inhalation Powder [Spiriva] 0.018mg
Tiotropium bromide (Spiriva) capsule 18μg once daily inhaled.
Other Names:
  • Spiriva
Drug: Salbutamol sulphate aerosol (Ventolin) 0.01mg
As needed use of salbutamol sulphate aerosol (Ventolin) when exacerbation happens
Other Names:
  • Ventolin
Experimental: 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.
Drug: Tiotropium Inhalation Powder [Spiriva] 0.018mg
Tiotropium bromide (Spiriva) capsule 18μg once daily inhaled.
Other Names:
  • Spiriva
Drug: Salbutamol sulphate aerosol (Ventolin) 0.01mg
As needed use of salbutamol sulphate aerosol (Ventolin) when exacerbation happens
Other Names:
  • Ventolin
Other: 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.
Drug: Salbutamol sulphate aerosol (Ventolin) 0.01mg
As needed use of salbutamol sulphate aerosol (Ventolin) when exacerbation happens
Other Names:
  • Ventolin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the inner luminal area (Ai) of the 3th to 9th generation bronchi at month 24
Time Frame: 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
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
Time Frame: 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
Ai accessed by endobronchial optical coherence tomography will be obtained at month 12.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the airway wall area percentage (Aw%) of the 3th to 9th generation bronchi at month 12
Time Frame: 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
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
Time Frame: 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
Aw% accessed by endobronchial optical coherence tomography will be obtained at month24.
Change from baseline in trough FEV1
Time Frame: Pulmonary function test will be performed at baseline, month 6, 12, 18 and 24.
To evaluate the effects of Tiotropium in improving lung function
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.
Time Frame: IOS will be performed at baseline, 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.
Change from baseline in peripheral airway resistance (R5-R20)
Time Frame: IOS will be performed at baseline, 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.
Total times of SABA usage
Time Frame: During the two years treatment period, times of SABA administration will be recored.
To evaluate the times of SABA administration
During the two years treatment period, times of SABA administration will be recored.
Total dosage of SABA usage
Time Frame: During the two years treatment period, the dosage of SABA administration will be recored.
To evaluate the dosage of SABA administration
During the two years treatment period, the dosage of SABA administration will be recored.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Institute of Respiratory Disease

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

January 21, 2019

First Submitted That Met QC Criteria

February 13, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESCOPD-20181001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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