Perception of Symptom Variability in COPD

NCT ID: NCT01753427

Last Updated: 2016-06-15

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

1058 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-11-30

Brief Summary

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The objective of the study is to assess patient's perception with stable state COPD on symptom variability and to describe how symptom variability impacts daily quality of life in Chinese COPD patient with moderate, severe or very severe airflow limitation from tier 3 hospitals in China where most of COPD patients are diagnosed and treated.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Provision of subject informed consent
* Out-patient
* Clinical diagnosis of COPD at least 6 months
* Lung function based on data available within 3 months in medical records confirming FEV1\<80% normal predicted (post-bronchodilator) and FEV1/FVC\<0.7 (post-bronchodilator)

Exclusion Criteria

* Participation in any interventional study involving investigational drugs; Patient inability to understand the study procedures or inability/reluctance to answer questionnaire
* Ongoing exacerbation of COPD or exacerbation within the previous 3 months. An exacerbation is defined as a worsening of COPD symptoms leading to a treatment with antibiotics and/or a short course of system steroids and/or hospitalisation or emergency
* History of asthma and/or allergic rhinitis, Lung cancer or any other significant respiratory disease such as bronchiectasis, lung fibrosis, interstitial lung disease, tuberculosis, sarcoidosis
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

Locations

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Research Site

Beijing, Beijing Municipality, China

Site Status

Research Site

Guangzhou, Guangdong, China

Site Status

Research Site

Wuhan, Hubei, China

Site Status

Research Site

Shanghai, Shanghai Municipality, China

Site Status

Research Site

Chengdu, Sichuan, China

Site Status

Research Site

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Related Links

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Other Identifiers

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NIS-RCN-XXX-2012/1

Identifier Type: -

Identifier Source: org_study_id

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