Research of Endobronchial Optical Coherence Tomography in Pre-COPD

NCT06436482 | Recruiting

• 1 other identifier: SichuanPPHGZ02
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Optical Coherence Tomography; Pulmonary Function

Keywords

Chronic Obstructive Pulmonary Disease; Optical Coherence Tomography; pre-stage

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Baseline clinical characteristics

  baseline

• BMI（Kg/m2)）

  baseline

• pulmonary function test (FEV1 predicted %)

  baseline

• FEV1/FVC ratio

  baseline

• MMEF 25/75

  baseline

Study Arms (3)

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

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

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

Interventions

Optical Coherence Tomography DEVICE

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); Control group; Pre-stage of Chronic Obstructive Pulmonary Disease (Pre-COPD)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Guanghong G Zhou, Master

  Sichuan Provincial People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Guanghong G Zhou, Master

CONTACT

86-18302880040; zhough0526@163.com

Guanghong G Zhou, Master

CONTACT

18302880040; zhough0526@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 31, 2024
• Study Start: March 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

CN (1)