Clinical trial NCT02600221: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma-COPD Overlap Syndrome
Keywords: ACOS
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-11-09
Enrollment: 2016
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: one day
Secondary outcomes:
measure: - 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.
timeFrame: one day
measure: - 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.
timeFrame: one day
measure: - The distribution of groups according to GOLD 2015 group definition (A,B,C,D) in patients with ACOS or COPD.
timeFrame: one day
measure: - The distribution of medication by drug class in patients with ACOS, Asthma and COPD.
timeFrame: one day
measure: - The proportions of previous diagnosis as asthma/COPD/chronic bronchitis/emphysema in the ACOS patients.
timeFrame: one day
measure: The number of Acute exacerbations history in 12 months before the visit
timeFrame: one day
measure: The severity of Acute exacerbations history in 12 months before the visit
timeFrame: one day
measure: The days of hospitalization or emergency room visit of Acute exacerbations history in 12 months before the visit
timeFrame: one day
measure: Severity of ACOS patients evaluated using CAT (mild, moderate, severe and very severe) in ACOS patients
timeFrame: one day
measure: Severity of ACOS patients evaluated using ACQ-5 (complete control, good control and uncontrolled) in ACOS patients
timeFrame: one day
measure: Severity of ACOS patients evaluated using mMRC (0, 1, 2, 3 and 4) in ACOS patients
timeFrame: one day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Chongqing
country: China
facility: Research Site
state: Chongqing
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Haikou
country: China
facility: Research Site
state: Hainan
city: Zhengzhou
country: China
facility: Research Site
state: Henan
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Hohhot
country: China
facility: Research Site
state: Inner Mongolia
city: Shenyang
country: China
facility: Research Site
state: Liaoning
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Xi'an
country: China
facility: Research Site
state: Shanxi
city: Chengdou
country: China
facility: Research Site
state: Sichuan
city: Tianjin
country: China
facility: Research Site
state: Tianjin
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
Study officials:
affiliation: First Hospital of China Medical University
name: Jian Kang, Doctor of Medicine
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.