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A Descriptive Study to Explore Certain Characteristics of Patients at Risk for Chronic Obstructive Pulmonary Disease (COPD) in a Primary Care Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01013922
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : November 19, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease
Chronic Obstructive Pulmonary Disease

Study Design

Study Type : Observational
Actual Enrollment : 309 participants
Official Title: A Descriptive Study to Explore Certain Characteristics of Patients at Risk for COPD in a Primary Care Setting
Study Start Date : October 2009
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
No treatment
Patients with a smoking history of 15 pack years or more.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01013922


Locations
Sweden
Research Site
Alingsas, Sweden
Research Site
Arvidsjaur, Sweden
Research Site
Askim, Sweden
Research Site
Atvidaberg, Sweden
Research Site
Bromma, Sweden
Research Site
Eslov, Sweden
Research Site
Falun, Sweden
Research Site
Gagnef, Sweden
Research Site
Goteborg, Sweden
Research Site
Hagfors, Sweden
Research Site
Helsingborg, Sweden
Research Site
Hisings Karra, Sweden
Research Site
Hollviken, Sweden
Research Site
Jarpen, Sweden
Research Site
Karlshamn, Sweden
Research Site
Karlskrona, Sweden
Research Site
Kil, Sweden
Research Site
Limhamn, Sweden
Research Site
Linkoping, Sweden
Research Site
Lulea, Sweden
Research Site
Stockholm, Sweden
Research Site
Timra, Sweden
Research Site
Varnamo, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Björn Tilling Åtvidabergs vårdcentral
Study Director: Georgios Stratelis AstraZeneca
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01013922     History of Changes
Other Study ID Numbers: NIS-RSE-DUM-2008/1
First Posted: November 16, 2009    Key Record Dates
Last Update Posted: November 19, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:
COPD
COPD-6
Spirometry
VC
FEV
FEV1

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases