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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04853225
• Other study ID #: 208630
• Status: Active, not recruiting
• Start date: April 22, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Prospective observational cohort study
Prospective observational cohort study

Locations

Country	Name	City	State
China	GSK Investigational Site	Dongguan	Guangdong
China	GSK Investigational Site	Dongguan	Guangdong
China	GSK Investigational Site	FoShan	Guangdong
China	GSK Investigational Site	Foshan	Guangdong
China	GSK Investigational Site	Foshan	Guangdong
China	GSK Investigational Site	Guangzhou	Guangdong
China	GSK Investigational Site	Guangzhou	Guangdong
China	GSK Investigational Site	Guangzhou	Guangdong
China	GSK Investigational Site	Guangzhou
China	GSK Investigational Site	Guangzhou
China	GSK Investigational Site	Guangzhou
China	GSK Investigational Site	Guangzhou
China	GSK Investigational Site	Guangzhou
China	GSK Investigational Site	Heyuan	Guangdong
China	GSK Investigational Site	Heyuan	Guangdong
China	GSK Investigational Site	Huizhou	Guangdong
China	GSK Investigational Site	Huizhou
China	GSK Investigational Site	Jiangmen	Guangdong
China	GSK Investigational Site	Jiangmen	Guangdong
China	GSK Investigational Site	Jieyang	Guangdong
China	GSK Investigational Site	Jieyang
China	GSK Investigational Site	Meizhou	Guangdong
China	GSK Investigational Site	Qingyuan	Guangdong
China	GSK Investigational Site	Shantou	Guangdong
China	GSK Investigational Site	Shantou	Guangdong
China	GSK Investigational Site	Shaoguan	Guangdong
China	GSK Investigational Site	Shaoguan	Guangdong
China	GSK Investigational Site	Shenzhen	Guangdong
China	GSK Investigational Site	Shenzhen	Guangdong
China	GSK Investigational Site	Shenzhen	Guangdong
China	GSK Investigational Site	Shenzhen	Guangdong
China	GSK Investigational Site	Shenzhen	Guangdong
China	GSK Investigational Site	Shenzhen
China	GSK Investigational Site	Shunde	Guangdong
China	GSK Investigational Site	Xiamen	Fujian
China	GSK Investigational Site	Yunfu	Guangdong
China	GSK Investigational Site	Zhanjiang	Guangdong
China	GSK Investigational Site	Zhaoqing	Guangdong
China	GSK Investigational Site	Zhongshan	Guangdong
China	GSK Investigational Site	Zhongshan	Guangdong
China	GSK Investigational Site	Zhuhai	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Guangzhou Institute of Respiratory Health (GIRH)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Change from Baseline in lung density	Lung density will be measured using High-resolution Computed tomography (HRCT).	Baseline and Up to 2.5 years
Primary	Change from Baseline in airway wall thickness	Airway wall thickness will be measured.	Baseline and Up to 2.5 years
Primary	Change from Baseline in daily step count	Daily step count will be measured using activity monitor.	Baseline and Up to 2.5 years
Primary	Number of participants with changes in sputum microbiome	Sputum samples will be collected for the assessment of sputum microbiome.	Up to 2.5 years