Status: Planned First registered on: 23/06/2020
Last updated on: 23/06/2020
1. Study identification
EU PAS Register NumberEUPAS35964
Official titleBurden and consequences of the use of COPD-related systemic corticosteroids
Study title acronymCOPD OCS study
Study typeObservational study
Brief description of the studyThis will be an observational, retrospective cohort study of patients who are or were diagnosed with COPD. Patterns of use, risk of comorbidities associated with COPD-related systemic corticosteroids (SCS) use and its related cost impact on COPD patients will be evaluated in the CPRD database. Those initiating SCS (SCS arm) will be compared to those not exposed to SCS (non-SCS arm/control arm). This cohort study will be comprised of a minimum 1-year baseline period. The index date for patients in the SCS arm is the date of their first recorded prescription for parenteral or oral COPD-related corticosteroids while the index date for those in the non-SCS arm is the nearest general practice (GP) visit to the matched-case index date. Patients will be followed-up to the end of their individual records which will be defined as either of the following: date of the last data extraction from the GP, date of leaving the GP, date of death, or any study outcome of interest. The study outcomes of interest are incidence of morbidity outcomes: type 2 diabetes mellitus, hypertension, cardio-/cerebrovascular disease (myocardial infarction, dyslipidaemia, congestive heart failure, cerebrovascular accident), osteoporosis, osteoporotic fracture, weight gain, sleep disorders, sleep apnoea, peptic ulcer, cataracts, glaucoma, depression/anxiety, psychosis, pneumonia, antibiotic treated infections, sudden death, and renal impairment. The worsening or recurrence of morbidity outcomes: type 2 diabetes, new osteoporosis related fractures, and pneumonia. HCRU and associated costs to the healthcare system will be described for different resource components as well as SCS-related all-cause and specified comorbid conditions. Exposure of SCS will be measured from index date to incidence of the outcome or to the end of a patient’s observation.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsOPRI Pte Ltd
Department/Research groupObservational and Pragmatic Research Institute Pte Ltd
Organisation/affiliationOPRI Pte Ltd
Website/Homepagewww.opri.sg
Details of (Primary) lead investigator
Title Professor
Last name Price
First name David
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed06/11/2019
Start date of data collection28/08/2020
Start date of data analysis28/08/2020
Date of interim report, if expected
Date of final study report30/04/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 15a Coles Lane
Address line 2Oakington 
Address line 3 
CityCambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom
Phone number (incl. country code)442081233923 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@opri.sg
Public Enquiries
Title Professor 
Last name Price 
First name David 
Address line 15a Coles Lane 
Address line 2Oakington 
Address line 3 
CityCambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom 
Phone number (incl. country code)442081233923 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@opri.sg 
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