Status: Planned First registered on: 04/09/2020
Last updated on: 04/09/2020
1. Study identification
EU PAS Register NumberEUPAS37065
Official titleAn observational cohort study to describe intermittent OCS utilisation and its association with adverse outcomes and healthcare resource use and costs in asthma using the OPCRD and CPRD databases.
Study title acronymThe burden of intermittent OCS use in asthma
Study typeObservational study
Brief description of the studyBackground/Rationale: Oral corticosteroids (OCS) are frequently prescribed for patients with respiratory conditions such as asthma. Despite evidence on the adverse outcomes of OCS, their use remains part of the clinical guidelines for asthma. There is evidence showing that relatively low cumulative doses of OCS can increase the risk of adverse outcomes and there is a wide consensus among physicians and researchers that the use of OCS should be limited to a minimum and should only be used when no other treatment option is available. Despite this OCS are still widely prescribed for patients with mild asthma. Whilst there is evidence showing increased risk of adverse events related to cumulative OCS dose there is little showing how patterns of intermittent OCS use are related to adverse events and related healthcare costs. Objectives: 1. To classify intermittent OCS prescriptions for patients with asthma and to describe longitudinal patterns of intermittent (acute) OCS use by Global Initiative for Asthma (GINA) step, and Inhaled Corticosteroids (ICS) and Short-Acting Beta-Agonists (SABA) use. 2. To assess the association between differing patterns of intermittent OCS use and OCS-related adverse events (AE) in patients with asthma 3. To describe the impact of different patterns of intermittent OCS use on the frequency of healthcare resource utilisation (HRU) in patients with asthma. 4. To describe the AE for patients with an average annual OCS dose of 250-499mg, 500-999mg, or =>1g of OCS during the follow up.
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
Multiple centres

In total how many centres are involved in this Study?2

OPRI Pte Ltd
CPRD
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 signed16/12/2019
Start date of data collection07/09/2020
Start date of data analysis05/10/2020
Date of interim report, if expected29/01/2021
Date of final study report05/04/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstra Zeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Heatley
First name Heath
Address line 1OPC UK
Address line 25 Coles Lane, 
Address line 3Oakington, 
CityCambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom
Phone number (incl. country code)441223967855 
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)44-1223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@rirl.org 
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