Investigation of Chronic Obstructive Pulmonary Disease (COPD) Phenotypes and Endotypes in China

Study Overview
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Brief Summary
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This is a non-drug interventional cohort study, which aims to investigate the clinical, radiological and biological factors associated with disease progression in COPD in China. Participants will be recruited from multiple hospitals across Guangdong province categorized as Type A hospitals (those at prefecture-level and above) and Type B hospitals (those below prefecture-level).

Official Title
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Investigation of the Clinical, Radiological and Biological Factors Associated With Disease Progression, Phenotypes and Endotypes of COPD in China

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Other: Prospective observational cohort study


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male or female participants, aged 50-80 years inclusive. A female is eligible only if she is of non-child bearing potential. Body mass index (BMI) less than (<)35. A signed and dated written informed consent is obtained prior to participation. Additional inclusion criteria for COPD participants: A Baseline (post-bronchodilator) (FEV1/FVC) ratio <70 percent (%). Clinically stable and has no exacerbations for at least 1 month prior to recruitment. Ever smoker or never smoker. Additional inclusion criteria for chronic bronchitis participants: Free from other significant diseases. Baseline post-bronchodilator FEV1/FVC ratio more than (>)70%. Chronic bronchitis is defined as at least 3 months of cough and phlegm in a year in the past 2 years. Clinically stable and has no exacerbations for at least 1 month prior to recruitment. Ever smoker or never smoker Additional inclusion criteria for healthy participants: Free from any significant diseases Baseline post-bronchodilator FEV1/FVC ratio >70%. A CAT score <10. Never smoker. Passive smoker is not eligible. Exclusion criteria: Having undergone lung surgery. Known respiratory disorders or significant inflammatory disease other than COPD. Serious, uncontrolled disease (including serious psychological disorders) Confirmed cancer, unless participants in remission for more than or equal to (>=)5 years. Participating or plan to participant in any clinical studies where investigational drugs were tested. Unable or unwilling to use required digital devices (sub- cohort only). Have evidence of alcohol or drug abuse. Have received a blood transfusion in the 4 weeks prior to study start. On long-term oral corticosteroids. Unable to walk. Unable to read and understand Mandarin Chinese. Additional exclusion criteria for COPD participants: Current primary diagnosis of asthma (participants with a primary diagnosis of COPD but who also had asthma [Asthma COPD overlap {ACO}] could be included). Known disorders other than COPD that may significantly impact clinical assessments Additional exclusion criteria for chronic bronchitis participants and healthy participants: Known disorders that may significantly impact clinical assessments. FVC <80% Predicted.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main cohort<br>COPD, chronic bronchitis and healthy participants (never smoker) from Type A and Type B hospitals will be included. | Other: Prospective observational cohort study<br>* Prospective observational cohort study<br>|
| Sub-cohort<br>COPD, chronic bronchitis and healthy participants (never smoker) from selected Type A hospitals will be included. | Other: Prospective observational cohort study<br>* Prospective observational cohort study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Forced expiratory volume in 1 second (FEV1) and Forced vital capacity (FVC) (Milliliters) | FEV1 and FVC will be measured using spirometry. | Baseline and Up to 2.5 years | 
| Rate of moderate and severe exacerbations per year | Moderate exacerbations require antibiotics and/or corticosteroids. Severe exacerbations require hospital admission. | Up to 2.5 years | 
| Change from Baseline in COPD assessment test (CAT) score | The CAT is an 8-item questionnaire used to measure the health status of participants with COPD. The experience is rated by participants on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0- 40. Higher scores indicates greater disease impact. | Baseline and Up to 2.5 years | 
| Change from Baseline in lung density | Lung density will be measured using High-resolution Computed tomography (HRCT). | Baseline and Up to 2.5 years | 
| Change from Baseline in airway wall thickness | Airway wall thickness will be measured. | Baseline and Up to 2.5 years | 
| Change from Baseline in daily step count | Daily step count will be measured using activity monitor. | Baseline and Up to 2.5 years | 
| Number of participants with changes in sputum microbiome | Sputum samples will be collected for the assessment of sputum microbiome. | Up to 2.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phenotypes, COPD, Endotypes, Chronic bronchitis, China, Healthy control