- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01013922
A Descriptive Study to Explore Certain Characteristics of Patients at Risk for Chronic Obstructive Pulmonary Disease (COPD) in a Primary Care Setting
November 18, 2010 updated by: AstraZeneca
A Descriptive Study to Explore Certain Characteristics of Patients at Risk for COPD in a Primary Care Setting
The purpose of this study is to explore if certain characteristics, easily detected within a regular primary care setting, may indicate that a patient at risk for COPD (45 ≤ age ≤ 80 years and a smoking history of ≥ 15 pack years) is prone to have a diagnosis of COPD according to Medical Products Agency guidelines.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
309
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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Alingsas, Sweden
- Research Site
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Arvidsjaur, Sweden
- Research Site
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Askim, Sweden
- Research Site
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Atvidaberg, Sweden
- Research Site
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Bromma, Sweden
- Research Site
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Eslov, Sweden
- Research Site
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Falun, Sweden
- Research Site
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Gagnef, Sweden
- Research Site
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Goteborg, Sweden
- Research Site
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Hagfors, Sweden
- Research Site
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Helsingborg, Sweden
- Research Site
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Hisings Karra, Sweden
- Research Site
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Hollviken, Sweden
- Research Site
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Jarpen, Sweden
- Research Site
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Karlshamn, Sweden
- Research Site
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Karlskrona, Sweden
- Research Site
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Kil, Sweden
- Research Site
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Limhamn, Sweden
- Research Site
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Linkoping, Sweden
- Research Site
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Lulea, Sweden
- Research Site
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Stockholm, Sweden
- Research Site
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Timra, Sweden
- Research Site
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Varnamo, Sweden
- 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 to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Primary care clinic
Description
Inclusion Criteria:
- Patients with a history of smoking one pack of cigarettes per day for 15 years or more
Exclusion Criteria:
- Known Chronic Obstructive Pulmonary Disease
- Known severe cardiovascular 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?
Cohorts and Interventions
Group / Cohort |
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No treatment
Patients with a smoking history of 15 pack years or more.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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The patients will test their lung function with a COPD-6 screener for COPD and compare with regular spirometry. Medical records will be checked for health care contacts with respiratory diagnosis during the last 24 months prior to the study visit.
Time Frame: There will only be one visit in the study
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There will only be one visit in the study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Björn Tilling, Åtvidabergs vårdcentral
- Study Director: Georgios Stratelis, AstraZeneca
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
October 1, 2009
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
November 13, 2009
First Submitted That Met QC Criteria
November 13, 2009
First Posted (Estimate)
November 16, 2009
Study Record Updates
Last Update Posted (Estimate)
November 19, 2010
Last Update Submitted That Met QC Criteria
November 18, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-RSE-DUM-2008/1
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.
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