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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema

NCT00570544

COPD Emphysema

COMPLETED

A Randomised, Double-blind, Placebo-controlled, 12 Week Trial to Evaluate the Effect of Tiotropium Inhalation Capsules (Spiriva) on the Magnitude of Exercise, Measured Using an Accelerometer, in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00144326

Pulmonary Disease, Chronic Obstructive

COMPLETED PHASE3

Tiotropium Handihaler vs. Tiotropium Respimat in COPD

NCT05838703

Chronic Obstructive Pulmonary Disease (COPD)

WITHDRAWN PHASE2

Tiotropium In Early Chronic Obstructive Pulmonary Disease Patients in China

NCT01455129

Chronic Obstructive Pulmonary Disease

COMPLETED PHASE4

Effect of Tiotropium (Spiriva) on Exercise Tolerance in COPD Patients

NCT00274508

Pulmonary Disease, Chronic Obstructive

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Airway Remodeling

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Tiotropium Inhalation Powder [Spiriva] 0.018mg

Intervention Type DRUG

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

Salbutamol sulphate aerosol (Ventolin) 0.01mg

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Tiotropium Inhalation Powder [Spiriva] 0.018mg

Intervention Type DRUG

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

Salbutamol sulphate aerosol (Ventolin) 0.01mg

Intervention Type DRUG

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

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.

Group Type OTHER

Salbutamol sulphate aerosol (Ventolin) 0.01mg

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tiotropium Inhalation Powder [Spiriva] 0.018mg

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

Intervention Type DRUG

Salbutamol sulphate aerosol (Ventolin) 0.01mg

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Spiriva Ventolin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No