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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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01013922
First received: November 13, 2009
Last updated: November 18, 2010
Last verified: November 2010
History of Changes
  Purpose

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
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Official Title: A Descriptive Study to Explore Certain Characteristics of Patients at Risk for COPD in a Primary Care Setting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 309
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment
Patients with a smoking history of 15 pack years or more.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by AstraZeneca

Additional 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
Study First Received: November 13, 2009
Last Updated: November 18, 2010
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013