Chronic Obstructive Pulmonary DiseaseEBOCTIPCOPDNCT06436482
Research of Endobronchial Optical Coherence Tomography in Pre-COPD
An observational study of Chronic Obstructive Pulmonary Disease and Optical Coherence Tomography, run by Sichuan Provincial People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Optical Coherence Tomography, Pulmonary Function
- What is being tested?
- Optical Coherence Tomography
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- 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.
Who may be able to join
- non-smoking with normal lung function, no other pulmonary diseases besides pulmonary nodule as indicated by chest computed tomography (CT).
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Guanghong Zhou, master, 18302880040, zhough0526@163.com
About this study
Official title: 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.
Read the 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
- Being tested
- Optical Coherence Tomography
- Keywords
- Chronic Obstructive Pulmonary Disease, Optical Coherence Tomography, pre-stage
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence TomographyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | non-smoking with normal lung function, no other pulmonary diseases besides pulmonary nodule as indicated by chest computed tomography (CT). Receives: 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 ) Receives: 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 Receives: Device: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Representative EB-OCT images of airway disorders
Representative EB-OCT images(airway remodeling, mucosa thickening ) in CP，Pre-COPD and COPD
Measured: 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.
Measured: baseline
Secondary outcomes (5)
Baseline clinical characteristics
Age（year）, gender(Male/female), smoking history(yes/no)
Measured: baseline
BMI（Kg/m2)）
Measured: baseline
pulmonary function test (FEV1 predicted %)
Baseline clinical characteristics
Measured: baseline
FEV1/FVC ratio
Measured: baseline
MMEF 25/75
Baseline clinical characteristics
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Mar 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guanghong Zhou, Sichuan Provincial People's Hospital
- Investigators
- Guanghong G Zhou, Master, Study director, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436482
- Sponsor's protocol ID
- SichuanPPHGZ02
- Acronym
- EBOCTIPCOPD
- Status last verified
- May 2024
- First submitted
- 23 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Endobronchial Optical Coherence Tomography in Pre-stage of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06436482
- Acronym / sponsor ID
- EBOCTIPCOPD / SichuanPPHGZ02
- Keywords
- Chronic Obstructive Pulmonary Disease, Optical Coherence Tomography, pre-stage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Device: Optical Coherence Tomographynon-smoking with normal lung function, no other pulmonary diseases besides pulmonary nodule as indicated by chest computed tomography (CT). |
| Pre-stage of Chronic Obstructive Pulmonary Disease (Pre-COPD) | – | Device: Optical Coherence TomographyPatients 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 ) |
| Chronic Obstructive Pulmonary Disease (COPD) | – | Device: Optical Coherence TomographyCOPD 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- non-smoking with normal lung function, no other pulmonary diseases besides pulmonary nodule as indicated by chest computed tomography (CT).
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Coherence TomographyPlacing 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. | Device | Chronic Obstructive Pulmonary Disease (COPD), Control group, Pre-stage of Chronic Obstructive Pulmonary Disease (Pre-COPD) |
Primary outcome
Representative EB-OCT images of airway disorders
Time frame: baseline
Representative EB-OCT images(airway remodeling, mucosa thickening ) in CP，Pre-COPD and COPD
EB-OCT parameters in different stages of COPD
Time frame: baseline
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.
5 secondary outcomes
Baseline clinical characteristics
Time frame: baseline
BMI（Kg/m2)）
Time frame: baseline
pulmonary function test (FEV1 predicted %)
Time frame: baseline
FEV1/FVC ratio
Time frame: baseline
MMEF 25/75
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guanghong G Zhou, Master study director
Sichuan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Optical Coherence Tomography, run by Sichuan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guanghong G Zhou, Master (86-18302880040, zhough0526@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Representative EB-OCT images of airway disorders (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.