Status: Finalised First registered on: 11/03/2019
Last updated on: 20/02/2020
1. Study identification
EU PAS Register NumberEUPAS28611
Official titleHidden Severe Asthma in Primary Care versus ISAR Cohort
Study title acronym
Study typeObservational study
Brief description of the studyTo identify, within asthma managed population, patients that have severe asthma but are “hidden” from specialist care using a large, real-life population-based cohort of patients in the UK. Then to compare the demographic and clinical characteristics of the “hidden” patients with severe asthma identified in primary care to those managed in specialist care. Primary objectives: • To construct criteria for identifying severe asthma in primary-care EMR databases based on their treatment and measures of control. • To compare the characteristics of “hidden” patients with severe asthma in primary care to those managed in specialist care (ISAR). Secondary objectives: • To describe the demographic and clinical profile of patients with severe asthma managed exclusively in primary care and are hidden from specialist care. • To describe the demographic and clinical profile of patients treated at low dose ICS/LABA and experiencing exacerbations. These patients may be unrecognised as potentially severe asthma patients. • To create a criteria-template for identifying these patients with severe asthma in other countries
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?
Yes

Respiratory Effectiveness Group (REG)
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 signed20/12/2018
Start date of data collection01/02/2019
Start date of data analysis01/03/201901/03/2019
Date of interim report, if expected27/03/2019
Date of final study report02/09/201920/02/2020
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 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@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@opri.sg 
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