Research of Endobronchial Optical Coherence Tomography in Pre-COPD (EBOCTIPCOPD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Function; Optical Coherence Tomography
• Intervention / Treatment: Device: Optical Coherence Tomography

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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Guanghong G Zhou, Master; Phone Number: 86-18302880040; Email: zhough0526@163.com
• Study Contact Backup: Name: Guanghong G Zhou, Master; Phone Number: 18302880040; Email: zhough0526@163.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Recruiting
      • Sichuan Provincial People's Hospital
      • Contact: Guanghong Zhou, master; Phone Number: 18302880040; Email: zhough0526@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pre-COPD: Pre-COPD was diagnosed based on GOLD 2022; Patients exhibit early pulmonary abnormalities, such as, CT scans show the presence of emphysema, bullae, and air trapping; COPD: COPD was diagnosed based on GOLD guideline; No acute exacerbations within 4 weeks; CT scans show no other pulmonary diseases besides COPD; pulmonary function test results were available from within the last 3 days. All COPD patients were treatment-naive except for those with at stage III-IV who received maintenance therapy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; non-smoking with normal lung function, no other pulmonary diseases besides pulmonary nodule as indicated by chest computed tomography (CT).	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.
Pre-stage of Chronic Obstructive Pulmonary Disease (Pre-COPD); Patients exhibit early pulmonary abnormalities, such as, CT scans show the presence of emphysema, bullae, and air trapping; pulmonary function manifested as preserved ratio impaired spirometry (PRISm). PRISm was defined as a normal ratio [the forced expiratory volume in one second (FEV1) / forced vital capacity (FVC) ≥ 0.7] after inhalation of a bronchodilator, but impaired ventilatory function [percentage of forced expiratory volume in the first second to the expected value (FEV1%) and/or percentage of FVC to the expected value (FVC%) < 80%], with concurrent structural changes in the lungs (such as emphysema) and/or physiological abnormalities (such as hyperinflation, decreased diffusion capacity, rapid decline in FEV1 )	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.
Chronic Obstructive Pulmonary Disease (COPD); COPD was diagnosed based on GOLD guideline [1]; No acute exacerbations within 4 weeks; CT scans show no other pulmonary diseases besides COPD; pulmonary function test results were available from within the last 3 days. All COPD patients were treatment-naive except for those with at stage III-IV who received maintenance therapy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Representative EB-OCT images of airway disorders	Representative EB-OCT images(airway remodeling, mucosa thickening ) in CP，Pre-COPD and COPD	baseline
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sichuan Provincial People's Hospital
• Investigators: Study Director: Guanghong G Zhou, Master, Sichuan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; Optical Coherence Tomography; pre-stage
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: SichuanPPHGZ02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No