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

Primary Purpose

Airway Remodeling

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Tiotropium Inhalation Powder [Spiriva] 0.018mg

Salbutamol sulphate aerosol (Ventolin) 0.01mg

About this trial

This is an interventional treatment trial for Airway Remodeling

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Arm Label

Tiotropium (0-12 month) + SABA as needed

Tiotropium (0-24 month) + SABA as needed

SABA as needed only

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

Change from baseline in trough FEV1

To evaluate the effects of Tiotropium in improving lung function

Change from baseline in resonant frequency (Fres) at month 6, 12, 18 and 24.

To evaluate the effects of Tiotropium in improving lung function

Change from baseline in peripheral airway resistance (R5-R20)

To evaluate the effects of Tiotropium in improving lung function

Total times of SABA usage

To evaluate the times of SABA administration

Total dosage of SABA usage

To evaluate the dosage of SABA administration

Full Information

NCT ID

NCT03842839

First Posted

January 21, 2019

Last Updated

September 27, 2022

Sponsor

Guangzhou Institute of Respiratory Disease

1. Study Identification

Unique Protocol Identification Number

NCT03842839

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangzhou Institute of Respiratory Disease

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Airway Remodeling

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tiotropium (0-12 month) + SABA as needed

Arm Type

Experimental

Arm Description

Arm Title

Tiotropium (0-24 month) + SABA as needed

Arm Type

Experimental

Arm Description

Arm Title

SABA as needed only

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Tiotropium Inhalation Powder [Spiriva] 0.018mg

Other Intervention Name(s)

Spiriva

Intervention Description

Tiotropium bromide (Spiriva) capsule 18μg once daily inhaled.

Intervention Type

Drug

Intervention Name(s)

Salbutamol sulphate aerosol (Ventolin) 0.01mg

Other Intervention Name(s)

Ventolin

Intervention Description

As needed use of salbutamol sulphate aerosol (Ventolin) when exacerbation happens

Primary Outcome Measure Information:

Title

Change from baseline in the inner luminal area (Ai) of the 3th to 9th generation bronchi at month 24

Description

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.

Title

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

Description

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.

Secondary Outcome Measure Information:

Title

Change from baseline in the airway wall area percentage (Aw%) of the 3th to 9th generation bronchi at month 12

Description

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.

Title

Change from baseline in the airway wall area percentage (Aw%) of the 3th to 9th generation bronchi at month 24

Description

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.

Title

Change from baseline in trough FEV1

Description

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.

Title

Change from baseline in resonant frequency (Fres) at month 6, 12, 18 and 24.

Description

To evaluate the effects of Tiotropium in improving lung function

Time Frame

IOS will be performed at baseline, month 6, 12, 18 and 24.

Title

Change from baseline in peripheral airway resistance (R5-R20)

Description

To evaluate the effects of Tiotropium in improving lung function

Time Frame

IOS will be performed at baseline, month 6, 12, 18 and 24.

Title

Total times of SABA usage

Description

To evaluate the times of SABA administration

Time Frame

During the two years treatment period, times of SABA administration will be recored.

Title

Total dosage of SABA usage

Description

To evaluate the dosage of SABA administration

Time Frame

During the two years treatment period, the dosage of SABA administration will be recored.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shiyue Li, MD

Phone

8620-83062896

lishiyue@gzhmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Shiyue Li, MD

12. IPD Sharing Statement

Learn more about this trial

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

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