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

NCT03842839 | Unknown

• 1 other identifier: ESCOPD-20181001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Remodeling

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (7)

• 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.

• 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.

• Change from baseline in trough FEV1

  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.

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

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

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

Study Arms (3)

Tiotropium (0-12 month) + SABA as needed

EXPERIMENTAL

* 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; Drug: Salbutamol sulphate aerosol (Ventolin) 0.01mg

Tiotropium (0-24 month) + SABA as needed

EXPERIMENTAL

* 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; Drug: Salbutamol sulphate aerosol (Ventolin) 0.01mg

SABA as needed only

OTHER

* 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

Interventions

Tiotropium Inhalation Powder [Spiriva] 0.018mg DRUG

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

Also known as: Spiriva

Tiotropium (0-12 month) + SABA as needed; Tiotropium (0-24 month) + SABA as needed

Salbutamol sulphate aerosol (Ventolin) 0.01mg DRUG

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

Also known as: Ventolin

SABA as needed only; Tiotropium (0-12 month) + SABA as needed; Tiotropium (0-24 month) + SABA as needed

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 40 yrs; Male or female Diagnosed with COPD
• Pre-bronchodilator FEV1 ≥80% pred ;
• Patients must be able to perform all study related procedures

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Airway Remodeling

Interventions

Tiotropium Bromide; Albuterol

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: February 15, 2019
• Study Start: October 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 29, 2022

Record last verified: 2022-09

Locations

CN (1)