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
Official title: A Descriptive Study to Explore Certain Characteristics of Patients at Risk for COPD in a Primary Care Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
COPD-6
Spirometry
VC
FEV
FEV1
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-11-16
Enrollment: 309
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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.


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

Primary outcomes:
measure: 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.
timeFrame: There will only be one visit in the study
Secondary outcomes:
Other outcomes:
Locations:
city: Alingsas
country: Sweden
facility: Research Site
city: Arvidsjaur
country: Sweden
facility: Research Site
city: Askim
country: Sweden
facility: Research Site
city: Atvidaberg
country: Sweden
facility: Research Site
city: Bromma
country: Sweden
facility: Research Site
city: Eslov
country: Sweden
facility: Research Site
city: Falun
country: Sweden
facility: Research Site
city: Gagnef
country: Sweden
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Hagfors
country: Sweden
facility: Research Site
city: Helsingborg
country: Sweden
facility: Research Site
city: Hisings Karra
country: Sweden
facility: Research Site
city: Hollviken
country: Sweden
facility: Research Site
city: Jarpen
country: Sweden
facility: Research Site
city: Karlshamn
country: Sweden
facility: Research Site
city: Karlskrona
country: Sweden
facility: Research Site
city: Kil
country: Sweden
facility: Research Site
city: Limhamn
country: Sweden
facility: Research Site
city: Linkoping
country: Sweden
facility: Research Site
city: Lulea
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Timra
country: Sweden
facility: Research Site
city: Varnamo
country: Sweden
facility: Research Site
Study officials:
affiliation: Åtvidabergs vårdcentral
name: Björn Tilling
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Georgios Stratelis
role: STUDY_DIRECTOR
References:
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.