## Protocol Section
### Identification Module
**NCT ID:** NCT06436482

**Acronym:** EBOCTIPCOPD

**Brief Title:** 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

#### Organization Study ID Info
**ID:** SichuanPPHGZ02
#### Organization
**Class:** OTHER
**Full Name:** Sichuan Provincial People's Hospital
### Status Module
#### Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Sichuan Provincial People's Hospital

#### Responsible Party

**Investigator Affiliation:** Sichuan Provincial People's Hospital

**Investigator Full Name:** Guanghong Zhou

**Investigator Title:** Attending physician

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Chronic Obstructive Pulmonary Disease

- Optical Coherence Tomography

- Pulmonary Function

**Keywords:**

- Chronic Obstructive Pulmonary Disease

- Optical Coherence Tomography

- pre-stage

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: Optical Coherence Tomography

**Label:** Control group

#### Arm Group 2

**Description:** 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 )

**Intervention Names:**

- Device: Optical Coherence Tomography

**Label:** Pre-stage of Chronic Obstructive Pulmonary Disease (Pre-COPD)

#### Arm Group 3

**Description:** 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

**Intervention Names:**

- Device: Optical Coherence Tomography

**Label:** Chronic Obstructive Pulmonary Disease (COPD)

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Chronic Obstructive Pulmonary Disease (COPD)

- Control group

- Pre-stage of Chronic Obstructive Pulmonary Disease (Pre-COPD)

**Description:** 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.

**Name:** Optical Coherence Tomography

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Representative EB-OCT images(airway remodeling, mucosa thickening ) in CP，Pre-COPD and COPD

**Measure:** Representative EB-OCT images of airway disorders

**Time Frame:** baseline

**Description:** 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.

**Measure:** EB-OCT parameters in different stages of COPD

**Time Frame:** baseline

#### Secondary Outcomes

**Description:** Age（year）, gender(Male/female), smoking history(yes/no)

**Measure:** Baseline clinical characteristics

**Time Frame:** baseline

**Measure:** BMI（Kg/m2)）

**Time Frame:** baseline

**Description:** Baseline clinical characteristics

**Measure:** pulmonary function test (FEV1 predicted %)

**Time Frame:** baseline

**Measure:** FEV1/FVC ratio

**Time Frame:** baseline

**Description:** Baseline clinical characteristics

**Measure:** MMEF 25/75

**Time Frame:** baseline

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 85 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** zhough0526@163.com

**Name:** Guanghong G Zhou, Master

**Phone:** 86-18302880040

**Role:** CONTACT

**Contact 2:**

**Email:** zhough0526@163.com

**Name:** Guanghong G Zhou, Master

**Phone:** 18302880040

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chengdu

**Contacts:**

***Contact 1:***

- **Email:** zhough0526@163.com

- **Name:** Guanghong Zhou, master

- **Phone:** 18302880040

- **Role:** CONTACT

**Country:** China

**Facility:** Sichuan Provincial People's Hospital

**State:** Sichuan

**Status:** RECRUITING

**Zip:** 610072

#### Overall Officials

**Official 1:**

**Affiliation:** Sichuan Provincial People's Hospital

**Name:** Guanghong G Zhou, Master

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11168

- Name: Lung Diseases

- Relevance: HIGH

- As Found: Pulmonary Disease

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: HIGH

- As Found: Obstructive Pulmonary Disease

- ID: M23449

- Name: Pulmonary Disease, Chronic Obstructive

- Relevance: HIGH

- As Found: Chronic Obstructive Pulmonary Disease

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008171

- Term: Lung Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000029424

- Term: Pulmonary Disease, Chronic Obstructive

### Intervention Browse Module - Browse Branches

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M5269

- Name: Bronchodilator Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
