Clinical trial NCT06436482: Research of Endobronchial Optical Coherence Tomography in Pre-COPD
Official title: Research of Endobronchial Optical Coherence Tomography in Pre-stage of Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Optical Coherence Tomography
Pulmonary Function
Keywords: Chronic Obstructive Pulmonary Disease
Optical Coherence Tomography
pre-stage
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Representative EB-OCT images of airway disorders
timeFrame: baseline
measure: EB-OCT parameters in different stages of COPD
timeFrame: baseline
Secondary outcomes:
measure: Baseline clinical characteristics
timeFrame: baseline
measure: BMI（Kg/m2)）
timeFrame: baseline
measure: pulmonary function test (FEV1 predicted %)
timeFrame: baseline
measure: FEV1/FVC ratio
timeFrame: baseline
measure: MMEF 25/75
timeFrame: baseline
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Provincial People's Hospital
name: Guanghong G Zhou, Master
role: STUDY_DIRECTOR
References: