Chronic Obstructive Pulmonary DiseaseNCT01655667
Comorbidities and Healthcare Utilisation: Indicators for Improving COPD Diagnosis
An observational study of Chronic Obstructive Pulmonary Disease, run by Research in Real-Life Ltd at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 38,859 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2010to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Research in Real Life Ltd
Cambridge, Cambridgeshire, CB24 3BA
About this study
Official title: Improving Diagnosis of COPD Through Characterisation of Comorbidities Present at, and Healthcare Utilisation Prior to, Diagnosis of COPD in UK. A Retrospective Primary Care Database.
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
Read the detailed description
Using real-world primary care clinical databases, ascertain whether 1) trends in respiratory resource utilisation prior to COPD diagnosis (including lower respiratory tract infections [LRTIs], consultations and hospitalisations) could be used as 'flags' to aid earlier diagnosis, and 2) characterize comorbid conditions present at the time of COPD diagnosis, and evaluate the relationship to COPD disease severity and age at diagnosis.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Diagnosis, Primary Care, Comorbidities, Healthcare utilisation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | All patients with a coded diagnosis of COPD entered into their electronic clinical record between 1990 and 2009. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startDec 2010
- Primary completionFeb 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 38,859 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research in Real-Life Ltd
- Sponsor type
- Research network
- Collaborators
- Department of Health, United Kingdom
- Responsible party
- Principal investigator, Shuna Gould, Research in Real-Life Ltd
- Investigators
- David B Price, MD, Principal investigator, Research in Real-Life LtdDermot Ryan, MBBS, Study director, University of EdinburghRupert Jones, MBBS, Study director, Peninsula College of Medinicne and DentistryEric Bateman, MD, Study director, University of Cape TownMatt Kearney, MPH, Study director, Department of Health, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655667
- Sponsor's protocol ID
- 015/11
- Status last verified
- Aug 2012
- First submitted
- 31 Jul 2012
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24717623
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diagnosis of COPD Through Characterisation of Comorbidities Present at, and Healthcare Utilisation Prior to, Diagnosis of COPD in UK. A Retrospective Primary Care Database.
- ClinicalTrials.gov ID
- NCT01655667
- Acronym / sponsor ID
- 015/11
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Diagnosis, Primary Care, Comorbidities, Healthcare utilisation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38,859 participants (actual)
- Lead sponsor
- Research in Real-Life LtdResearch network
- Collaborators
- Department of Health, United Kingdom
- Study start
- Dec 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Using real-world primary care clinical databases, ascertain whether 1) trends in respiratory resource utilisation prior to COPD diagnosis (including lower respiratory tract infections [LRTIs], consultations and hospitalisations) could be used as 'flags' to aid earlier diagnosis, and 2) characterize comorbid conditions present at the time of COPD diagnosis, and evaluate the relationship to COPD disease severity and age at diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | – | –All patients with a coded diagnosis of COPD entered into their electronic clinical record between 1990 and 2009. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
- Derived from this study: PubMed 24717623Jones 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David B Price, MD principal investigator
Research in Real-Life Ltd
Dermot Ryan, MBBS study director
University of Edinburgh
Rupert Jones, MBBS study director
Peninsula College of Medinicne and Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Research in Real-Life Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01655667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2012; AzTrials last refreshed its copy on 6 Nov 2026.