- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01325948
Cross-sectional Study to Investigate the Effects of Chronic Obstructive Pulmonary Disease on Daily Life Activities (COPD LIFE)
July 20, 2011 updated by: AstraZeneca
Cross-sectional Observational Study to Investigate the Effects of Chronic Obstructive Pulmonary Disease on Daily Life Activities
The purpose of this study is to investigate the effects of Chronic Obstructive Pulmonary Disease (COPD) on daily life activities in patients with COPD and also to determine the socio-demographic profile, daily life style and needs of the patients with COPD.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
497
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Adana, Turkey
- Research Site
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Ankara, Turkey
- Research Site
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Antalya, Turkey
- Research Site
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Aydin, Turkey
- Research Site
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Bartin, Turkey
- Research Site
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Bolu, Turkey
- Research Site
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Burdur, Turkey
- Research Site
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Bursa, Turkey
- Research Site
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Gaziantep, Turkey
- Research Site
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Gebze, Turkey
- Research Site
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Giresun, Turkey
- Research Site
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Isparta, Turkey
- Research Site
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Istanbul, Turkey
- Research Site
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Izmir, Turkey
- Research Site
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Karabuk, Turkey
- Research Site
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Kayseri, Turkey
- Research Site
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Konya, Turkey
- Research Site
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Manisa, Turkey
- Research Site
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Mersin, Turkey
- Research Site
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Yozgat, Turkey
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Outpatients from health institutions where the patients with COPD are treated
Description
Inclusion Criteria:
- Diagnosis of COPD
- Outpatient treatment for any reason
- Current or ex-smoker
Exclusion Criteria:
- An exacerbation of COPD that still lasts or that was experienced within last 3 months
- History of asthma and/or allergic rhinitis
- The presence of another important respiratory disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients with COPD
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Effect of COPD on daily activities
Time Frame: 1 year
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The distribution of the patients according to their answers, as Yes / No / Unknown, given to the questions of patient questionnaire about the effect of COPD on daily life and which daily activities are limited will be calculated as percentage.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patients' socio-demographic profiles, daily life conditions and needs and expectations from therapy
Time Frame: Baseline
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The answers the patients give to the questions about socio-demographic profiles, daily life conditions and needs and their expectations from the therapy will be summarized as percentages: Age and gender, educational background, place of residence, marital status and life conditions, concomitant diseases, smoking status, the diagnosis of COPD and its clinical characteristics basic knowledge of the patient about COPD daily life of the patient, expectations from the therapy.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Zeynep Goztas, AstraZeneca Turkey
- Principal Investigator: Mehmet Polatli, Adnan Menderes University Faculty of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
March 21, 2011
First Submitted That Met QC Criteria
March 29, 2011
First Posted (Estimate)
March 30, 2011
Study Record Updates
Last Update Posted (Estimate)
July 21, 2011
Last Update Submitted That Met QC Criteria
July 20, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-RTR-XXX-2011/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.