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COMPLETED
NCT03842839
NA

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

Sponsor: Guangzhou Institute of Respiratory Disease

View on ClinicalTrials.gov

Summary

This randomized, open-label, three-arm clinical trial evaluated the effects of tiotropium on airway remodeling in patients with GOLD stage 1 COPD using endobronchial optical coherence tomography (EB-OCT). Participants were randomly assigned to receive tiotropium for 12 months followed by withdrawal for months 12-24, tiotropium continuously for 24 months, or SABA as needed without regular long-acting bronchodilator therapy. Airway morphology, pulmonary function, impulse oscillometry, and SABA use were assessed during the 24-month follow-up.

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2019-08-01

Completion Date

2025-05-07

Last Updated

2026-10-21

Healthy Volunteers

No

Interventions

DRUG

Tiotropium Inhalation Powder [Spiriva] 0.018mg

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

DRUG

Salbutamol sulphate aerosol (Ventolin) 0.1mg

Salbutamol inhalation aerosol (Ventolin), 100 μg per actuation, was available as needed for symptom relief throughout the 24-month study period.

Locations (1)

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

Guangzhou, Guangdong, China