Research of Endobronchial Optical Coherence Tomography in Pre-COPD

Recruiting

• Conditions: Optical Coherence Tomography; Pulmonary Function; Chronic Obstructive Pulmonary Disease

• Registration Number: NCT06436482
• Lead Sponsor: Sichuan Provincial People's Hospital

Brief Summary

The pre-stage of Chronic Obstructive Pulmonary Disease (Pre-COPD) is challenging to diagnose. However, identifying Pre-COPD is a crucial step in the prevention and management of COPD. Endobronchial optical coherence tomography showed the value of diagnosis in Pre-COPD and COPD in previous researchs.

Detailed Description

We recruited COPD patients (stage I-II, n=15; stage III-IV, n= 15), Pre-COPD (n= 20) and healthy never-smokers (healthy human, n=21). Age,gender,BMI, smoking history, spirometry, chest computed tomography (CT), bronchoscopy and EB-OCT were performed. Inner luminal area (Ai) and airway wall area (Aw) of bronchi which inner perimeter was 10mm, 20mm and 30mm were measured using EB-OCT respectively. By analyzing and studying the above situation, we aim to discover the application value of OCT in Pre-COPD

Study Timeline

• Study Start: 2023-03-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-23
• Study First Submitted QC: 2024-05-30
• Last Update Submitted: 2024-05-30
• Study First Posted: 2024-05-31
• Last Update Posted: 2024-05-31
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• non-smoking with normal lung function, no other pulmonary diseases besides pulmonary nodule as indicated by chest computed tomography (CT).

Exclusion Criteria

• (1) patients with contraindication of bronchoscopy, (2) patients who are participating in other clinical studies, (3) patients with poor compliance who are believed by the researchers to be unable to cooperate for the completion of the examination and follow-up, and (4) women who were pregnant.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EB-OCT parameters in different stages of COPD	baseline	Inner luminal area (Ai，mm) and airway wall area (Aw,mm2) of bronchi which inner perimeter was 10mm, 20mm and 30mm were measured using EB-OCT respectively.
Representative EB-OCT images of airway disorders	baseline	Representative EB-OCT images(airway remodeling, mucosa thickening ) in CP，Pre-COPD and COPD

Secondary Outcome Measures

Name	Time	Method
Baseline clinical characteristics	baseline	Age（year）, gender(Male/female), smoking history(yes/no)
pulmonary function test (FEV1 predicted %)	baseline	Baseline clinical characteristics
FEV1/FVC ratio	baseline
MMEF 25/75	baseline	Baseline clinical characteristics
BMI（Kg/m2)）	baseline

Trial Locations

Locations (1)

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China