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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04853225
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : July 27, 2021
Sponsor:
Collaborator:
Guangzhou Institute of Respiratory Health (GIRH)
Information provided by (Responsible Party):
GlaxoSmithKline

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
Pulmonary Disease, Chronic Obstructive Other: Prospective observational cohort study

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Study Type : Observational
Estimated 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 : April 22, 2020
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort 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




Primary Outcome Measures :
  1. Change from Baseline in Forced expiratory volume in 1 second (FEV1) and Forced vital capacity (FVC) (Milliliters) [ Time Frame: Baseline and Up to 2.5 years ]
    FEV1 and FVC will be measured using spirometry.

  2. Rate of moderate and severe exacerbations per year [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline and Up to 2.5 years ]
    Airway wall thickness will be measured.

  6. Change from Baseline in daily step count [ Time Frame: 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 [ Time Frame: Up to 2.5 years ]
    Sputum samples will be collected for the assessment of sputum microbiome.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04853225


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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China, Fujian
GSK Investigational Site Recruiting
Xiamen, Fujian, China, 361004
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Huiqing Zeng         
China, Guangdong
GSK Investigational Site Recruiting
Dongguan, Guangdong, China, 523059
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ping Zhang         
GSK Investigational Site Recruiting
Dongguan, Guangdong, China, 523326
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Lei Wu         
GSK Investigational Site Recruiting
Foshan, Guangdong, China, 528041
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Zhilong Wu         
GSK Investigational Site Recruiting
Foshan, Guangdong, China
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Yonghua Chen         
GSK Investigational Site Recruiting
FoShan, Guangdong, China
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Fu Rong         
GSK Investigational Site Recruiting
Guangzhou, Guangdong, China, 510120
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jinping Zheng         
GSK Investigational Site Recruiting
Guangzhou, Guangdong, China, 510150
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Liping Wei         
GSK Investigational Site Recruiting
Guangzhou, Guangdong, China, 510515
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Shaoxi Cai         
GSK Investigational Site Recruiting
Heyuan, Guangdong, China, 517199
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Yongqing Ye         
GSK Investigational Site Recruiting
Heyuan, Guangdong, China, 517300
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Liqing Liu         
GSK Investigational Site Recruiting
Huizhou, Guangdong, China, 516000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Feng Wu         
GSK Investigational Site Recruiting
Jiangmen, Guangdong, China
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Facai Fan         
GSK Investigational Site Recruiting
Jiangmen, Guangdong, China
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Xiuzhen Tang         
GSK Investigational Site Recruiting
Jiangmen, Guangdong, China
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Yanming Huang         
GSK Investigational Site Recruiting
Jieyang, Guangdong, China
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Junhe Zhuang         
GSK Investigational Site Recruiting
Meizhou, Guangdong, China, 514700
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Qianyun Zhang         
GSK Investigational Site Recruiting
Qingyuan, Guangdong, China, 510030
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Dongbo Guangdong Tian         
GSK Investigational Site Recruiting
Shantou, Guangdong, China, 515031
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Qichuan Zhang         
GSK Investigational Site Recruiting
Shantou, Guangdong, China
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Zhongsheng Zheng         
GSK Investigational Site Recruiting
Shaoguan, Guangdong, China, 512026
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Yinlou Yang         
GSK Investigational Site Recruiting
Shaoguan, Guangdong, China, 512600
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Changli Yang         
GSK Investigational Site Recruiting
Shenzhen, Guangdong, China, 518020
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Rongchang Chen         
GSK Investigational Site Recruiting
Shenzhen, Guangdong, China, 518100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Fa Long         
GSK Investigational Site Recruiting
Shenzhen, Guangdong, China, 518101
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Shaoxiao Qiu         
GSK Investigational Site Recruiting
Shenzhen, Guangdong, China, 518104
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Yong Jiang         
GSK Investigational Site Recruiting
Shenzhen, Guangdong, China, 518116
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Songming Zhuo         
GSK Investigational Site Recruiting
Shunde, Guangdong, China, 528300
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jiaowu Li         
GSK Investigational Site Recruiting
Yunfu, Guangdong, China, 527400
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Yongxiang Liang         
GSK Investigational Site Recruiting
Zhanjiang, Guangdong, China, 524001
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Bin Wu         
GSK Investigational Site Recruiting
Zhaoqing, Guangdong, China, 526400
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Zijie Li         
GSK Investigational Site Recruiting
Zhongshan, Guangdong, China, 528400
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jianping Liang         
GSK Investigational Site Recruiting
Zhongshan, Guangdong, China, 528415
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Yancong Li         
GSK Investigational Site Recruiting
Zhuhai, Guangdong, China, 519000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Yanju He         
China
GSK Investigational Site Recruiting
Guangzhou, China, 510080
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Yubiao Guo         
GSK Investigational Site Recruiting
Guangzhou, China, 510220
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Yu Zeng         
GSK Investigational Site Recruiting
Guangzhou, China, 510260
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Pusheng Xu         
GSK Investigational Site Recruiting
Guangzhou, China, 510700
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Gao Yi         
GSK Investigational Site Recruiting
Guangzhou, China, 511400
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Yinhuan Li         
GSK Investigational Site Recruiting
Huizhou, China, 516001
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Changqing Lin         
GSK Investigational Site Recruiting
Jieyang, China
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Weihan Lin         
GSK Investigational Site Recruiting
Shenzhen, China, 518005
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Liteng Yang         
Sponsors and Collaborators
GlaxoSmithKline
Guangzhou Institute of Respiratory Health (GIRH)
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04853225    
Other Study ID Numbers: 208630
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive