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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings