Clincosm LogoSign in Get a demo

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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04853225
Collaborator
Guangzhou Institute of Respiratory Health (GIRH) (Other)
2,000
Enrollment
41
Locations
50.3
Anticipated Duration (Months)
48.8
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Prospective observational cohort study

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Investigation of the Clinical, Radiological and Biological Factors Associated With Disease Progression, Phenotypes and Endotypes of COPD in China
Actual Study Start Date :
Apr 22, 2020
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Main cohort

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

Other: Prospective observational cohort study
Prospective observational cohort study
Sub-cohort

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

Other: Prospective observational cohort study
Prospective observational cohort study

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in Forced expiratory volume in 1 second (FEV1) and Forced vital capacity (FVC) (Milliliters) [Baseline and Up to 2.5 years]

    FEV1 and FVC will be measured using spirometry.

  2. Rate of moderate and severe exacerbations per year [Up to 2.5 years]

    Moderate exacerbations require antibiotics and/or corticosteroids. Severe exacerbations require hospital admission.

  3. Change from Baseline in COPD assessment test (CAT) score [Baseline and Up to 2.5 years]

    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.

  4. Change from Baseline in lung density [Baseline and Up to 2.5 years]

    Lung density will be measured using High-resolution Computed tomography (HRCT).

  5. Change from Baseline in airway wall thickness [Baseline and Up to 2.5 years]

    Airway wall thickness will be measured.

  6. Change from Baseline in daily step count [Baseline and Up to 2.5 years]

    Daily step count will be measured using activity monitor.

  7. Number of participants with changes in sputum microbiome [Up to 2.5 years]

    Sputum samples will be collected for the assessment of sputum microbiome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 ] 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Xiamen Fujian China 361004
2 GSK Investigational Site Dongguan Guangdong China 523059
3 GSK Investigational Site Dongguan Guangdong China 523326
4 GSK Investigational Site FoShan Guangdong China 528000
5 GSK Investigational Site Foshan Guangdong China 528041
6 GSK Investigational Site Foshan Guangdong China 528200
7 GSK Investigational Site Guangzhou Guangdong China 510120
8 GSK Investigational Site Guangzhou Guangdong China 510150
9 GSK Investigational Site Guangzhou Guangdong China 510515
10 GSK Investigational Site Heyuan Guangdong China 517199
11 GSK Investigational Site Heyuan Guangdong China 517300
12 GSK Investigational Site Huizhou Guangdong China 516000
13 GSK Investigational Site Jiangmen Guangdong China 529000
14 GSK Investigational Site Jiangmen Guangdong China 529700
15 GSK Investigational Site Jieyang Guangdong China 515300
16 GSK Investigational Site Meizhou Guangdong China 514700
17 GSK Investigational Site Qingyuan Guangdong China 510030
18 GSK Investigational Site Shantou Guangdong China 515031
19 GSK Investigational Site Shantou Guangdong China 515041
20 GSK Investigational Site Shaoguan Guangdong China 512026
21 GSK Investigational Site Shaoguan Guangdong China 512600
22 GSK Investigational Site Shenzhen Guangdong China 518020
23 GSK Investigational Site Shenzhen Guangdong China 518100
24 GSK Investigational Site Shenzhen Guangdong China 518101
25 GSK Investigational Site Shenzhen Guangdong China 518104
26 GSK Investigational Site Shenzhen Guangdong China 518116
27 GSK Investigational Site Shunde Guangdong China 528300
28 GSK Investigational Site Yunfu Guangdong China 527400
29 GSK Investigational Site Zhanjiang Guangdong China 524001
30 GSK Investigational Site Zhaoqing Guangdong China 526400
31 GSK Investigational Site Zhongshan Guangdong China 528400
32 GSK Investigational Site Zhongshan Guangdong China 528415
33 GSK Investigational Site Zhuhai Guangdong China 519000
34 GSK Investigational Site Guangzhou China 510080
35 GSK Investigational Site Guangzhou China 510220
36 GSK Investigational Site Guangzhou China 510260
37 GSK Investigational Site Guangzhou China 510700
38 GSK Investigational Site Guangzhou China 511400
39 GSK Investigational Site Huizhou China 516001
40 GSK Investigational Site Jieyang China 522000
41 GSK Investigational Site Shenzhen China 518005

Sponsors and Collaborators

  • GlaxoSmithKline
  • Guangzhou Institute of Respiratory Health (GIRH)

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT04853225
Other Study ID Numbers:
  • 208630
First Posted:
Apr 21, 2021
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GlaxoSmithKline
COPD
Phenotypes
Endotypes
Chronic bronchitis
China
Healthy control
Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Aug 4, 2022