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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04853225
Other study ID # 208630
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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