Status: Finalised First registered on: 31/07/2015
Last updated on: 31/07/2015
1. Study identification
EU PAS Register NumberEUPAS10483
Official titleIncreasing ICS Dose vs Add-on Therapy in Children with Asthma
Study title acronymPaediatric Asthma Step-up
Study typeObservational study
Brief description of the studyA historical observational database study UK using primary care data to evaluate the comparative effectiveness of different paediatric asthma step-up options with respect to asthma control at 12 months, specifically ICS dose increase; addition of LABA to existing ICS (as either a separate inhaler or as part of a fixed dose combination) or the addition of LTRA to existing LABA therapy.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
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 belongsRIRL
Department/Research group
Organisation/affiliationResearch in Real Life Ltd.
Website/Homepagewww.rirl.org
Details of (Primary) lead investigator
Title Professor
Last name Turner
First name Stephen
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 signed03/12/201203/12/2012
Start date of data collection07/01/201307/01/2013
Start date of data analysis
Date of interim report, if expected
Date of final study report15/07/201515/07/2015
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
OtherRespiratory Effectiveness Group70
Research in Real Life Ltd30
5. Contact details for enquiries
Scientific Enquiries
Title Miss
Last name Chisholm
First name Alison
Address line 15 Woodview
Address line 2 
Address line 3 
CityArundel 
Postcode 
CountryUnited Kingdom
Phone number (incl. country code)441903883797 
Alternative phone number 
Fax number (incl. country code) 
Email address alison@effectivenessevaluation.org
Public Enquiries
Title Miss 
Last name Chisholm 
First name Alison 
Address line 15 
Address line 2 
Address line 3 
CityArundel 
Postcode 
CountryUnited Kingdom 
Phone number (incl. country code)441903883797 
Alternative phone number 
Fax number (incl. country code) 
Email address alison@effectivenessevaluation.org 
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