Back to resultsA Descriptive Study to Explore Certain Characteristics of Patients at Risk for Chronic Obstructive Pulmonary Disease (COPD) in a Primary Care Setting
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Locations
Sweden
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, COPD-6, Spirometry, VC, FEV, FEV1
Eligibility 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
Sites / Locations
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Arms of the Study
Arm 1
Arm Type
Arm Label
No treatment
Arm Description
Patients with a smoking history of 15 pack years or more.
Outcomes
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01013922
Brief Title
A Descriptive Study to Explore Certain Characteristics of Patients at Risk for Chronic Obstructive Pulmonary Disease (COPD) in a Primary Care Setting
Official Title
A Descriptive Study to Explore Certain Characteristics of Patients at Risk for COPD in a Primary Care Setting
Study Type
Observational
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, COPD-6, Spirometry, VC, FEV, FEV1
7. Study Design
Enrollment
309 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No treatment
Arm Description
Patients with a smoking history of 15 pack years or more.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Study Population Description
Primary care clinic
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Björn Tilling
Organizational Affiliation
Åtvidabergs vårdcentral
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Georgios Stratelis
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Alingsas
Country
Sweden
Facility Name
Research Site
City
Arvidsjaur
Country
Sweden
Facility Name
Research Site
City
Askim
Country
Sweden
Facility Name
Research Site
City
Atvidaberg
Country
Sweden
Facility Name
Research Site
City
Bromma
Country
Sweden
Facility Name
Research Site
City
Eslov
Country
Sweden
Facility Name
Research Site
City
Falun
Country
Sweden
Facility Name
Research Site
City
Gagnef
Country
Sweden
Facility Name
Research Site
City
Goteborg
Country
Sweden
Facility Name
Research Site
City
Hagfors
Country
Sweden
Facility Name
Research Site
City
Helsingborg
Country
Sweden
Facility Name
Research Site
City
Hisings Karra
Country
Sweden
Facility Name
Research Site
City
Hollviken
Country
Sweden
Facility Name
Research Site
City
Jarpen
Country
Sweden
Facility Name
Research Site
City
Karlshamn
Country
Sweden
Facility Name
Research Site
City
Karlskrona
Country
Sweden
Facility Name
Research Site
City
Kil
Country
Sweden
Facility Name
Research Site
City
Limhamn
Country
Sweden
Facility Name
Research Site
City
Linkoping
Country
Sweden
Facility Name
Research Site
City
Lulea
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Timra
Country
Sweden
Facility Name
Research Site
City
Varnamo
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
22270480
Citation
Thorn J, Tilling B, Lisspers K, Jorgensen L, Stenling A, Stratelis G. Improved prediction of COPD in at-risk patients using lung function pre-screening in primary care: a real-life study and cost-effectiveness analysis. Prim Care Respir J. 2012 Jun;21(2):159-66. doi: 10.4104/pcrj.2011.00104.
Results Reference
derived
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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
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