Clinical trial NCT04853225: Investigation of Chronic Obstructive Pulmonary Disease (COPD) Phenotypes and Endotypes in China
Official title: Investigation of the Clinical, Radiological and Biological Factors Associated With Disease Progression, Phenotypes and Endotypes of COPD in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
Phenotypes
Endotypes
Chronic bronchitis
China
Healthy control
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Guangzhou Institute of Respiratory Health (GIRH)
First posted: 2021-04-21
Enrollment: 2000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with COPD, chronic bronchitis without fixed airflow limitation and never smoker healthy participants will be included in the study.

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Forced expiratory volume in 1 second (FEV1) and Forced vital capacity (FVC) (Milliliters)
timeFrame: Baseline and Up to 2.5 years
measure: Rate of moderate and severe exacerbations per year
timeFrame: Up to 2.5 years
Secondary outcomes:
measure: Change from Baseline in COPD assessment test (CAT) score
timeFrame: Baseline and Up to 2.5 years
measure: Change from Baseline in lung density
timeFrame: Baseline and Up to 2.5 years
measure: Change from Baseline in airway wall thickness
timeFrame: Baseline and Up to 2.5 years
measure: Change from Baseline in daily step count
timeFrame: Baseline and Up to 1.5 years
measure: Number of participants with changes in sputum microbiome
timeFrame: Up to 2.5 years
Other outcomes:
Locations:
city: Dongguan
country: China
facility: GSK Investigational Site
city: Dongguan
country: China
facility: GSK Investigational Site
city: FoShan
country: China
facility: GSK Investigational Site
city: Foshan
country: China
facility: GSK Investigational Site
city: Foshan
country: China
facility: GSK Investigational Site
city: Guangzhou
country: China
facility: GSK Investigational Site
city: Guangzhou
country: China
facility: GSK Investigational Site
city: Guangzhou
country: China
facility: GSK Investigational Site
city: Guangzhou
country: China
facility: GSK Investigational Site
city: Guangzhou
country: China
facility: GSK Investigational Site
city: Guangzhou
country: China
facility: GSK Investigational Site
city: Guangzhou
country: China
facility: GSK Investigational Site
city: Guangzhou
country: China
facility: GSK Investigational Site
city: Heyuan
country: China
facility: GSK Investigational Site
city: Heyuan
country: China
facility: GSK Investigational Site
city: Huizhou
country: China
facility: GSK Investigational Site
city: Huizhou
country: China
facility: GSK Investigational Site
city: Jiangmen
country: China
facility: GSK Investigational Site
city: Jiangmen
country: China
facility: GSK Investigational Site
city: Jieyang
country: China
facility: GSK Investigational Site
city: Jieyang
country: China
facility: GSK Investigational Site
city: Meizhou
country: China
facility: GSK Investigational Site
city: Qingyuan
country: China
facility: GSK Investigational Site
city: Shantou
country: China
facility: GSK Investigational Site
city: Shantou
country: China
facility: GSK Investigational Site
city: Shaoguan
country: China
facility: GSK Investigational Site
city: Shenzhen
country: China
facility: GSK Investigational Site
city: Shenzhen
country: China
facility: GSK Investigational Site
city: Shenzhen
country: China
facility: GSK Investigational Site
city: Shenzhen
country: China
facility: GSK Investigational Site
city: Shenzhen
country: China
facility: GSK Investigational Site
city: Shenzhen
country: China
facility: GSK Investigational Site
city: Shunde
country: China
facility: GSK Investigational Site
city: Wengyuan
country: China
facility: GSK Investigational Site
city: Xiamen
country: China
facility: GSK Investigational Site
city: Yunfu
country: China
facility: GSK Investigational Site
city: Zhangshan
country: China
facility: GSK Investigational Site
city: Zhangshan
country: China
facility: GSK Investigational Site
city: Zhanjiang
country: China
facility: GSK Investigational Site
city: Zhaoqing
country: China
facility: GSK Investigational Site
city: Zhuhai
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: