Status: Ongoing First registered on: 17/08/2015
Last updated on: 10/10/2018
1. Study identification
EU PAS Register NumberEUPAS10684
Official titleComparative Effectiveness of Extra-Fine Particle Inhaled Corticosteroid (ICS) and Alternative Guideline-Recommended Step-Up Options in Pre-School Children
Study title acronym
Study typeObservational study
Brief description of the studyThis will be a prospectively planned matched cohort study drawing on retrospective, electronic medical records from the Optimum Patient Care Research Database (OPCRD). The small particle size of extra –fine ICS may be particularly relevant for younger, preschool (<5 years) children, in whom a greater proportion of airways are classified as small. The aim of this study is to test the hypothesis that use of EF ICS in pre-school children (i.e. ≤5 years of age) with asthma/wheeze will achieve better outcomes than treatment alternatives (i.e. NEF ICS, LTRA, or SABA) .
Was this study requested by a regulator?Don't know
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 signed30/08/2015
Start date of data collection01/09/201524/09/2015
Start date of data analysis09/10/2015
Date of interim report, if expected
Date of final study report06/05/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherREG100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 116 Raffles Quay
Address line 2#33-03 
Address line 3Hong Leong Building 
CitySingapore 
Postcode 
CountrySingapore
Phone number (incl. country code)441223967829 
Alternative phone number 
Fax number (incl. country code) 
Email address david@rirl.org
Public Enquiries
Title Professor 
Last name Price 
First name David 
Address line 116 Raffles Quay 
Address line 2#33-03 
Address line 3Hong Leong Building 
CitySingapore 
Postcode 
CountrySingapore 
Phone number (incl. country code)441223967829 
Alternative phone number 
Fax number (incl. country code) 
Email address david@rirl.org 
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