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

Asthma-COPD Overlap Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600221
• Other study ID #: D2287R00102
• Status: Completed
• Phase: N/A
• First received: October 29, 2015
• Last updated: October 16, 2017
• Start date: October 22, 2015
• Est. completion date: October 24, 2016

Study information

• Verified date: October 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To investigate the distributions of the patients with ACOS, asthma and COPD over age 40 with chronic airflow limitation in China.

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 information / eligibility

• Status: Completed
• Enrollment: 2016
• Est. completion date: October 24, 2016
• Est. primary completion date: October 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Asthma
• Asthma-COPD Overlap Syndrome
• Syndrome

Locations

Country	Name	City	State
China	Research Site	Beijing	Beijing
China	Research Site	Changsha	Hunan
China	Research Site	Chengdou	Sichuan
China	Research Site	Chongqing	Chongqing
China	Research Site	Guangzhou	Guangdong
China	Research Site	Haikou	Hainan
China	Research Site	Hangzhou	Zhejiang
China	Research Site	Hohhot	Inner Mongolia
China	Research Site	Shanghai	Shanghai
China	Research Site	Shenyang	Liaoning
China	Research Site	Tianjin	Tianjin
China	Research Site	Xi'an	Shanxi
China	Research Site	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	- 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
Secondary	- 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
Secondary	- The distribution of groups according to GOLD 2015 group definition (A,B,C,D) in patients with ACOS or COPD.		one day
Secondary	- The distribution of medication by drug class in patients with ACOS, Asthma and COPD.		one day
Secondary	- The proportions of previous diagnosis as asthma/COPD/chronic bronchitis/emphysema in the ACOS patients.		one day
Secondary	The number of Acute exacerbations history in 12 months before the visit		one day
Secondary	The severity of Acute exacerbations history in 12 months before the visit		one day
Secondary	The days of hospitalization or emergency room visit of Acute exacerbations history in 12 months before the visit		one day
Secondary	Severity of ACOS patients evaluated using CAT (mild, moderate, severe and very severe) in ACOS patients		one day
Secondary	Severity of ACOS patients evaluated using ACQ-5 (complete control, good control and uncontrolled) in ACOS patients		one day
Secondary	Severity of ACOS patients evaluated using mMRC (0, 1, 2, 3 and 4) in ACOS patients		one day

External Links

•   CSR Synopsis