Find Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials Near You
A Translational Study in Patients With COPD and Early COPD to Describe Patient Clinical Characteristics, Treatment Patterns, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes That May Support Future Development of Personalized Treatment Strategies in Chinese Population
Status: Recruiting
Location: See all (12) locations...
Study Type: Observational
SUMMARY
This is an observational study into more comprehensive understanding, including the trajectories of lung function decline, inflammatory/immunological mechanisms on early COPD, clinical outcomes and relevant endotypes on physician-diagnosed COPD. The sponsor will follow up all participants initially for 1-year period. The follow-up period may extend up to 3 years depending upon emerging data and feasibility assessment by the sponsor.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: f
View:
• Capable of giving signed ICF
• Able to perform acceptable lung function testing for FEV1 according to American Thoracic Society and European Respiratory Society 2019 acceptability criteria.
• Able and willing to comply with the requirements of the protocol including ability to read, write, be fluent in the translated language of all participants facing questionnaires used at center.
• Participants will be allowed to enroll into other studies while taking part in this study. However, permission from the Steering Committee must be obtained to enroll or allow the continued participation of a participant enrolled in another study.
Locations
Other Locations
China
Research Site
NOT_YET_RECRUITING
Beijing
Research Site
NOT_YET_RECRUITING
Changsha
Research Site
NOT_YET_RECRUITING
Chengdu
Research Site
RECRUITING
Guangzhou
Research Site
NOT_YET_RECRUITING
Hefei
Research Site
NOT_YET_RECRUITING
Nanjing
Research Site
NOT_YET_RECRUITING
Nanning
Research Site
NOT_YET_RECRUITING
Shanghai
Research Site
NOT_YET_RECRUITING
Shenyang
Research Site
NOT_YET_RECRUITING
Wuhan
Research Site
NOT_YET_RECRUITING
Xuzhou
Research Site
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date:2024-06-05
Estimated Completion Date:2027-10-21
Participants
Target number of participants:850
Treatments
Cohort A
Healthy controls from asthma translational study: at least 50 healthy participants aged 30 or older.
Cohort B
early COPD, normal lung function with symptoms approximately 200 smokers or ex-smokers, early COPD participants at 30 to 45 years of age (inclusive) with normal lung function defined as FEV1/FVC ratio \> 70% (lower limit of normal) and FEV1 \> 80% of predicted normal with symptoms defined as presence of chronic cough and/or chronic sputum and/or breathlessness equivalent to mMRC Grade 1 or higher, with any of the risk factors below:~* History suggestive of COPD exacerbation;~* Evidence of emphysema on CT scan;~* Evidence of small airways disease on CT scan or oscillometry.
Cohort C1
Approximately 100 physician diagnosed COPD participants with mild airflow limitation defined as post-bronchodilation FEV1/FVC \< 70% and FEV1 ≥ 80% of predicted. Participants at 30 to 50 years of age (inclusive)
Cohort C2
Approximately 100 physician diagnosed COPD participants with mild airflow limitation defined as post-bronchodilation FEV1/FVC \< 70% and FEV1 ≥ 80% of predicted. Defined as participants elder than 50 years of age (exclusive)
Corhort D
Moderate to very severe COPD Approximately 450 COPD participants (males and females aged 50 years or older) with moderate to very severe airflow limitation defined as post-bronchodilation FEV1/FVC \< 70% and FEV1 ≥ 25% and \<80% of predicted, and presence of respiratory symptoms quivalent to CAT ≥ 10 or mMRC ≥ 2.