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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02600221
First received: October 29, 2015
Last updated: November 16, 2016
Last verified: November 2016
  Purpose
To investigate the distributions of the patients with ACOS, asthma and COPD over age 40 with chronic airflow limitation in China.

Condition
Asthma-COPD Overlap Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 [ Time Frame: one day ]

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

Enrollment: 2180
Study Start Date: October 2015
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02600221

Locations
China, Beijing
Research Site
Beijing, Beijing, China
China, Chongqing
Research Site
Chongqing, Chongqing, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Hainan
Research Site
Haikou, Hainan, China
China, Henan
Research Site
Zhengzhou, Henan, China
China, Hunan
Research Site
Changsha, Hunan, China
China, Inner Mongolia
Research Site
Hohhot, Inner Mongolia, China
China, Liaoning
Research Site
Shenyang, Liaoning, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
China, Shanxi
Research Site
Xi'an, Shanxi, China
China, Sichuan
Research Site
Chengdou, Sichuan, China
China, Tianjin
Research Site
Tianjin, Tianjin, China
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Jian Kang, Doctor of Medicine First Hospital of China Medical University
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02600221     History of Changes
Other Study ID Numbers: D2287R00102
Study First Received: October 29, 2015
Last Updated: November 16, 2016

Keywords provided by AstraZeneca:
ACOS

Additional relevant MeSH terms:
Syndrome
Asthma
Disease
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 27, 2017