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
- Conditions
- Asthma-COPD Overlap Syndrome
- Registration Number
- NCT02600221
- Lead Sponsor
- AstraZeneca
- Brief Summary
To investigate the distributions of the patients with ACOS, asthma and COPD over age 40 with chronic airflow limitation in China.
- Detailed Description
Sites must be tier 3 hospitals in China. Investigators will mainly be determined according to the following criteria:
* Respiratory physicians working in the respiratory department of tier 3 hospitals
* To include the expected number of patients in a maximum of 12 months, physicians should manage a reasonable number of asthma, COPD or ACOS over age 40 with persistent airflow limitation (post-BD FEV1/FVC\<0.7).
* Physicians should have patients' spirometric data available in the patient's medical files (post-BD FEV1%pred and post-BD FEV1/FVC).
This NIS will collect the data (e.g. medical record, patient or physician-reported data) from about 2000 consecutive outpatients with persistent airflow limitation(post-BD FEV1/FVC\<0.7) in about 20 sites in China for one year. Each site will recruit about 50-150 patients successively.
The data will be collected under routine clinical practice. The treatments or examinations will be determined by their treating physicians. The data are expected to reflect the actual situation about ACOS.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2016
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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method - 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 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 - 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 number of Acute exacerbations history in 12 months before the visit one day The severity of Acute exacerbations history in 12 months before the visit one day The days of hospitalization or emergency room visit of Acute exacerbations history in 12 months before the visit one day Severity of ACOS patients evaluated using CAT (mild, moderate, severe and very severe) in ACOS patients one day Severity of ACOS patients evaluated using ACQ-5 (complete control, good control and uncontrolled) in ACOS patients one day Severity of ACOS patients evaluated using mMRC (0, 1, 2, 3 and 4) in ACOS patients one day
Trial Locations
- Locations (1)
Research Site
🇨🇳Hangzhou, Zhejiang, China