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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

NCT ID: NCT02600221

Last Updated: 2017-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2016 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-22

Study Completion Date

2016-10-24

Brief Summary

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

Detailed Description

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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.

Conditions

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Asthma-COPD Overlap Syndrome

Keywords

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ACOS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jian Kang, Doctor of Medicine

Role: PRINCIPAL_INVESTIGATOR

First Hospital of China Medical University

Locations

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Research Site

Beijing, Beijing Municipality, China

Site Status

Research Site

Chongqing, Chongqing Municipality, China

Site Status

Research Site

Guangzhou, Guangdong, China

Site Status

Research Site

Haikou, Hainan, China

Site Status

Research Site

Zhengzhou, Henan, China

Site Status

Research Site

Changsha, Hunan, China

Site Status

Research Site

Hohhot, Inner Mongolia, China

Site Status

Research Site

Shenyang, Liaoning, China

Site Status

Research Site

Shanghai, Shanghai Municipality, China

Site Status

Research Site

Xi’an, Shanxi, China

Site Status

Research Site

Chengdou, Sichuan, China

Site Status

Research Site

Tianjin, Tianjin Municipality, China

Site Status

Research Site

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 33103591 (View on PubMed)

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3996&filename=ACOS_CSR_synopsis.pdf

CSR Synopsis

Other Identifiers

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D2287R00102

Identifier Type: -

Identifier Source: org_study_id