NCT01655667

Brief Summary

To characterise and understand the current UK COPD population including demographics, active comorbidities and missed opportunities for COPD diagnosis in the years previous to diagnosis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38,859

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

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

December 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2012

Completed
Last Updated

August 2, 2012

Status Verified

August 1, 2012

Enrollment Period

2 months

First QC Date

July 31, 2012

Last Update Submit

August 1, 2012

Conditions

Keywords

DiagnosisPrimary CareComorbiditiesHealthcare utilisation

Study Arms (1)

Chronic Obstructive Pulmonary Disease

All patients with a coded diagnosis of COPD entered into their electronic clinical record between 1990 and 2009.

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects aged 40 years or older, with an electronically coded diagnosis of COPD made between 1990 and 2009, a minimum of three years continuous practice data including two years prior to and one year post diagnosis to ensure patients recieved COPD therapy post diagnosis (defined as two or more prescriptions for COPD therapies in the 12 months post diagnosis year 1). COPD therapies included short- and long-acting bronchodilators, inhaled corticosteroids, theophylline and leukotriene receptor antagonists.

You may qualify if:

  • Aged 40 years or older
  • Electronically coded diagnosis of COPD made between 1990 and 2009
  • A minimum of three years continuous practice data including two years prior to and one year post diagnosis to ensure patients recieved COPD therapy post diagnosis
  • Recieved two or more prescriptions for COPD therapies in the 12 months post diagnosis year 1.

You may not qualify if:

  • Aged less than 40 years
  • No diagnosis of COPD between 1990 and 2009
  • Less than three years continuous practice data including two years prior to and one year post diagnosis
  • Less than two prescriptions for COPD therapies in the 12 months post diagnosis year 1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research in Real Life Ltd

Cambridge, Cambridgeshire, CB24 3BA, United Kingdom

Location

Related Publications (1)

  • Jones RC, Price D, Ryan D, Sims EJ, von Ziegenweidt J, Mascarenhas L, Burden A, Halpin DM, Winter R, Hill S, Kearney M, Holton K, Moger A, Freeman D, Chisholm A, Bateman ED; Respiratory Effectiveness Group. Opportunities to diagnose chronic obstructive pulmonary disease in routine care in the UK: a retrospective study of a clinical cohort. Lancet Respir Med. 2014 Apr;2(4):267-76. doi: 10.1016/S2213-2600(14)70008-6. Epub 2014 Feb 13.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDisease

Condition Hierarchy (Ancestors)

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

Study Officials

  • David B Price, MD

    Research in Real-Life Ltd

    PRINCIPAL INVESTIGATOR
  • Dermot Ryan, MBBS

    University of Edinburgh

    STUDY DIRECTOR
  • Rupert Jones, MBBS

    Peninsula College of Medinicne and Dentistry

    STUDY DIRECTOR
  • Eric Bateman, MD

    University of Cape Town

    STUDY DIRECTOR
  • Matt Kearney, MPH

    Department of Health, United Kingdom

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor David Price

Study Record Dates

First Submitted

July 31, 2012

First Posted

August 2, 2012

Study Start

December 1, 2010

Primary Completion

February 1, 2011

Study Completion

June 1, 2012

Last Updated

August 2, 2012

Record last verified: 2012-08

Locations