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

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

Study Overview

• Status: Completed
• Conditions: Asthma-COPD Overlap Syndrome

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.

• Study Type: Observational
• Enrollment (Actual): 2016

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
- 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
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Jian Kang, Doctor of Medicine, First Hospital of China Medical University

Publications and helpful links

General Publications

• 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.

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2015
• Primary Completion (Actual): October 24, 2016
• Study Completion (Actual): October 24, 2016

Study Registration Dates

• First Submitted: October 29, 2015
• First Submitted That Met QC Criteria: November 6, 2015
• First Posted (Estimate): November 9, 2015

Study Record Updates

• Last Update Posted (Actual): October 17, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: ACOS
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Lung Diseases; Hypersensitivity, Immediate; Disease; Bronchial Diseases; Connective Tissue Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Pulmonary Disease, Chronic Obstructive; Syndrome; Asthma; Undifferentiated Connective Tissue Diseases; Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome
• Other Study ID Numbers: D2287R00102