Optical Coherence Tomography for Assessment of the Treatment Effect of Tiotropium in Early Stage of COPD

• Status: Unknown status
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The study aims to explore the reversibility of airway remodeling by Endobronchial Optical Coherence Tomography (EB-OCT). In this study, EB-OCT is used to assess the treatment effect of Tiotropium in early stage of COPD. Investigators recruit COPD patients in Grade A and Grade C according to GOLD 2019. Patients in Grade A will begin to use Tiotropium once daily, and EB-OCT, pulmonary function test and chest CT will be performed in baseline, 6 months, 1 year and 2 year. Patients in Grade C will begin to use LABA+LAMA (including but not limited to Olodaterol / Tiotropium) or LAMA (Tiotropium) , same testing will be performed as patients in Grade A. Primary endpoint is airway parameters accessed by EB-OCT. And secondary end points are FEV1 and CT accessed pulmonary emphysema.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangzhou Institute of Respiratory Disease
• Treatments: Olodaterol; Tiotropium Bromide

Criteria

Inclusion Criteria:

• Patients diagnosed with COPD, and be labelled Grade A and C according to "ABCD" assessment tool of the 2019 GOLD.

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.