Treatment and Exacerbation in COPD Subjects
Retrospective Comparative Effectiveness Study Assessing Treatment and Rates of Exacerbation Among Chronic Obstructive Pulmonary Disease Subjects in England
1 other identifier
observational
60,243
1 country
1
Brief Summary
This is a study comparing the effects of ICS containing treatments in patients with chronic obstructive pulmonary disease (COPD) in a real world setting, using the UK Clinical Practice Research Datalink (CPRD) linked with Hospital Episode Statistics (HES). The main outcome to be assessed is exacerbation rates.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 9, 2017
CompletedFirst Submitted
Initial submission to the registry
December 13, 2017
CompletedFirst Posted
Study publicly available on registry
December 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2019
CompletedSeptember 14, 2020
September 1, 2020
2.2 years
December 13, 2017
September 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute Exacerbation
Observational study with 10 year follow-up
10 years
Secondary Outcomes (1)
Pneumonia
10 years
Study Arms (1)
Observation
Cohort of patients with COPD
Interventions
Participants will be followed as per local routine primary healthcare practice
Eligibility Criteria
We will include all patients ≥40 years-old, with a validated diagnosis of COPD (29) recorded between the 1st of January 2006 and 29 Feb 2016 and incident use of one of the therapies under investigation during the study period. Eligible patients must have a smoking history, data recorded at least 12 months prior to the study index date and have up to standard (UTS) data as defined by CPRD (Appendix A lists Read codes for identification and characterization of the COPD population). The COPD definition has been validated in the CPRD against a reference standard of physician review of patient notes by the Imperial College research team. These definitions have high Positive Predictive Value (PPV) \>85%, and will be used in this analysis. All eligible CPRD GOLD patients will be included in the descriptive analysis, regardless of their eligibility for data linkage to HES, ONS and IMD data. The follow-up and analytical statistics will only be applied to patients eligible for linkage.
You may qualify if:
- \- All adult COPD patients aged ≥40, with a smoking history, incident prescription of a study therapy, and research acceptable data.
You may not qualify if:
- \- Any subjects with less than 12 months of UTS data prior to index date.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
London, United Kingdom
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2017
First Posted
December 18, 2017
Study Start
June 9, 2017
Primary Completion
August 30, 2019
Study Completion
August 30, 2019
Last Updated
September 14, 2020
Record last verified: 2020-09