NCT01013922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
309

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Shorter than P25 for all trials

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 16, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

November 19, 2010

Status Verified

November 1, 2010

Enrollment Period

5 months

First QC Date

November 13, 2009

Last Update Submit

November 18, 2010

Conditions

Keywords

COPDCOPD-6SpirometryVCFEVFEV1

Outcome Measures

Primary Outcomes (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.

    There will only be one visit in the study

Study Arms (1)

No treatment

Patients with a smoking history of 15 pack years or more.

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • Patients with a history of smoking one pack of cigarettes per day for 15 years or more

You may not qualify if:

  • Known Chronic Obstructive Pulmonary Disease
  • Known severe cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Research Site

Alingsås, Sweden

Location

Research Site

Arvidsjaur, Sweden

Location

Research Site

Askim, Sweden

Location

Research Site

Åtvidaberg, Sweden

Location

Research Site

Bromma, Sweden

Location

Research Site

Eslöv, Sweden

Location

Research Site

Falun, Sweden

Location

Research Site

Gagnef, Sweden

Location

Research Site

Gothenburg, Sweden

Location

Research Site

Hagfors, Sweden

Location

Research Site

Helsingborg, Sweden

Location

Research Site

Hisings Kärra, Sweden

Location

Research Site

Höllviken, Sweden

Location

Research Site

Järpen, Sweden

Location

Research Site

Karlshamn, Sweden

Location

Research Site

Karlskrona, Sweden

Location

Research Site

Kil, Sweden

Location

Research Site

Limhamn, Sweden

Location

Research Site

Linköping, Sweden

Location

Research Site

Luleå, Sweden

Location

Research Site

Stockholm, Sweden

Location

Research Site

Timrå, Sweden

Location

Research Site

Värnamo, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Björn Tilling

    Åtvidabergs vårdcentral

    PRINCIPAL INVESTIGATOR
  • Georgios Stratelis

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 13, 2009

First Posted

November 16, 2009

Study Start

October 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

November 19, 2010

Record last verified: 2010-11

Locations