Status: Finalised First registered on: 21/01/2015
Last updated on: 21/01/2015
1. Study identification
EU PAS Register NumberEUPAS8391
Official titleReal-world effectiveness of extrafine vesrus standard particle inhaled corticosteroids: A comparative effectiveness analysis of extrafine (EF) hydrofluoroalkane beclometasone (HFA-BDP) and Ciclesonide versus commonly prescribed standard particle inhaled corticosteroids for patients prescribed asthma therapy in The Netherlands.
Study title acronymExtrafine vesrus stand particle ICS effectiveness
Study typeObservational study
Brief description of the studyProject Description: To compare the effectiveness (in terms of exacerbation prevention and asthma control) of extra-fine vs standard particle ICS in asthma patients initiating or stepping-up ICS therapy in the Netherlands Patient population: patients receiving asthma therapy other than ICS (adult and paediatric) and initiating ICS therapy as either extra-fine particle ICS (QVAR + Ciclesonide) or standard particle ICS (FP + non-EF-BDP) Data source: Pharmacy and hospital records from the PHARMO Database Network (The Netherlands)
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 Dr
Last name Miglio
First name Cristiana
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

PHARMO Institute
Countries in which this study is being conducted
National study

Netherlands
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/12/201301/12/2013
Start date of data collection01/12/201301/12/2013
Start date of data analysis01/06/201401/01/2014
Date of interim report, if expected26/06/201426/06/2014
Date of final study report22/12/201422/12/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTeva100
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 116 Raffles Quay
Address line 2#33-03 
Address line 3Hong Leong Building 
CitySingapore 
Postcode048581 
CountrySingapore
Phone number (incl. country code)44-1223967829 
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 1Singapore 
Address line 2 
Address line 3 
CitySingapore 
Postcode 
CountrySingapore 
Phone number (incl. country code)44-1223967829 
Alternative phone number 
Fax number (incl. country code) 
Email address david@rirl.org 
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