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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06436482
Other study ID # SichuanPPHGZ02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date July 1, 2024

Study information

Verified date May 2024
Source Sichuan Provincial People's Hospital
Contact Guanghong G Zhou, Master
Phone 86-18302880040
Email zhough0526@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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


Intervention

Device:
Optical Coherence Tomography
Placing the probe of OCT in RB10c through the working channel of bronchoscope for real time dynamic scanning and collecting OCT parameters from participants in different groups.

Locations

Country Name City State
China Sichuan Provincial People's Hospital Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Representative EB-OCT images of airway disorders Representative EB-OCT images(airway remodeling, mucosa thickening ) in CP,Pre-COPD and COPD baseline
Primary EB-OCT parameters in different stages of COPD 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. baseline
Secondary Baseline clinical characteristics Age(year), gender(Male/female), smoking history(yes/no) baseline
Secondary BMI(Kg/m2)) baseline
Secondary pulmonary function test (FEV1 predicted %) Baseline clinical characteristics baseline
Secondary FEV1/FVC ratio baseline
Secondary MMEF 25/75 Baseline clinical characteristics baseline
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