A Non-interventional Study to Investigate the Current Situation of Asthma-COPD Overlap Syndrome in Patients Over Age 40 With Persistent Airflow Limitation in China
1 other identifier
observational
2,016
1 country
13
Brief Summary
To investigate the distributions of the patients with ACOS, asthma and COPD over age 40 with chronic airflow limitation in China.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
Shorter than P25 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 22, 2015
CompletedFirst Submitted
Initial submission to the registry
October 29, 2015
CompletedFirst Posted
Study publicly available on registry
November 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2016
CompletedOctober 17, 2017
October 1, 2017
1 year
October 29, 2015
October 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of ACOS among the patients over age 40 with persistent airflow limitation (post-BD FEV1/FVC<0.7) based on GINA and GOLD 2015 definition
one day
Secondary Outcomes (11)
- The proportions of COPD and asthma, respectively, among the patients over age 40 with persistent airflow limitation (post-BD FEV1/FVC<0.7) based on GINA and GOLD 2015 definition.
one day
- The distributions of the severity of airflow limitation according to GOLD lung function grading based on post-BD FEV1 in patients with ACOS, COPD or asthma.
one day
- The distribution of groups according to GOLD 2015 group definition (A,B,C,D) in patients with ACOS or COPD.
one day
- The distribution of medication by drug class in patients with ACOS, Asthma and COPD.
one day
- The proportions of previous diagnosis as asthma/COPD/chronic bronchitis/emphysema in the ACOS patients.
one day
- +6 more secondary outcomes
Eligibility Criteria
The study population will be about 2000 outpatients, men or women, over age 40, with a clinical diagnosis of asthma, COPD or ACOS with persistent airflow limitation（post-BD FEV1/FVC\<0.7）in China from Q4,2015 to Q3,2016.
You may qualify if:
- Outpatients, age ≥ 40 years Clinically diagnosed as asthma, COPD/chronic bronchitis/emphysema or ACOS at least 12 months With persistent airflow limitation (post-BD FEV1/FVC\<0.7) Signed informed consent forms
You may not qualify if:
- Have been involved in other clinical trial within 3 months Having other respiratory diseases which can influence airflow, such as lung cancer, tuberculosis, pneumonia, bronchiectasis, etc With acute exacerbation Inability to understand the study procedures or inability/reluctance to answer questionnaire judged by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (13)
Research Site
Beijing, Beijing Municipality, China
Research Site
Chongqing, Chongqing Municipality, China
Research Site
Guangzhou, Guangdong, China
Research Site
Haikou, Hainan, China
Research Site
Zhengzhou, Henan, China
Research Site
Changsha, Hunan, China
Research Site
Hohhot, Inner Mongolia, China
Research Site
Shenyang, Liaoning, China
Research Site
Shanghai, Shanghai Municipality, China
Research Site
Xi’an, Shanxi, China
Research Site
Chengdou, Sichuan, China
Research Site
Tianjin, Tianjin Municipality, China
Research Site
Hangzhou, Zhejiang, China
Related Publications (1)
Kang J, Zheng J, Cai B, Wen F, Yao W, Zhang X, Chen Y, Wang G, Li W, Cao J. Current situation of asthma-COPD overlap in Chinese patients older than 40 years with airflow limitation: a multicenter, cross-sectional, non-interventional study. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620961699. doi: 10.1177/1753466620961699.
PMID: 33103591DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jian Kang, Doctor of Medicine
First Hospital of China Medical University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2015
First Posted
November 9, 2015
Study Start
October 22, 2015
Primary Completion
October 24, 2016
Study Completion
October 24, 2016
Last Updated
October 17, 2017
Record last verified: 2017-10