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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01013922
Other study ID # NIS-RSE-DUM-2008/1
Secondary ID
Status Completed
Phase N/A
First received November 13, 2009
Last updated November 18, 2010
Start date October 2009
Est. completion date March 2010

Study information

Verified date November 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 309
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 80 Years
Eligibility 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 Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
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

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. There will only be one visit in the study No
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