Status: Finalised First registered on: 21/04/2016
Last updated on: 16/01/2017
1. Study identification
EU PAS Register NumberEUPAS13238
Official titleReal-life effectiveness evaluation of budesonide/formoterol (BF) Spiromax for the management of asthma and COPD
Study title acronym
Study typeObservational study
Brief description of the studyFour complimentary post-marketing retrospective observational studies to evaluate the real-life effectiveness and cost-effectiveness of BF Spiromax and to characterise patients prescribed BF Spiromax in the two years following product launch in the United Kingdom
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 groupResearch in Real Life Ltd
Organisation/affiliationOPRI Pte Ltd
Website/Homepagewww.rirl.org
Details of (Primary) lead investigator
Title Dr
Last name Voorham
First name Jaco
Is this study being carried out with the collaboration of a research network?
No
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 signed20/03/201520/03/2015
Start date of data collection16/09/201516/09/2015
Start date of data analysis09/05/2016
Date of interim report, if expected29/01/201629/01/2016
Date of final study report03/02/201716/01/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTeva Pharmaceutical Industries100
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 
Postcode 
CountryUnited Kingdom
Phone number (incl. country code)44-1223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@rirl.org
Public Enquiries
Title Professor 
Last name Price 
First name David 
Address line 15a Coles Lane 
Address line 2Oakington 
Address line 3 
CityCambridge 
Postcode 
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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