Research of Endobronchial Optical Coherence Tomography in Pre-COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

— EBOCTIPCOPD  

Official title:

Research of Endobronchial Optical Coherence Tomography in Pre-stage of Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06436482
• Other study ID #: SichuanPPHGZ02
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Optical Coherence Tomography
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Function

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