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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Other: Prospective observational cohort study

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04853225

208630

Details and patient eligibility

About

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).

Enrollment: 2,005 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

2,005 participants in 2 patient groups

Main cohort

Description:

COPD, chronic bronchitis and healthy participants (never smoker) from Type A and Type B hospitals will be included.

Treatment:

Other: Prospective observational cohort study

Sub-cohort

Description:

COPD, chronic bronchitis and healthy participants (never smoker) from selected Type A hospitals will be included.

Treatment:

Other: Prospective observational cohort study