Status: Finalised First registered on: 11/03/2016
Last updated on: 12/07/2016
1. Study identification
EU PAS Register NumberEUPAS12762
Official titleIncidence of oral thrush in COPD patients prescribed ICS as part of ICS/LABA therapy
Study title acronym
Study typeObservational study
Brief description of the studyA historical cohort, UK database study in patients with COPD comparing the incidence of oral thrush in those prescribed ICS as part of fixed-dose combination ICS/LABA therapies, with that in patients prescribed long-acting bronchodilator therapies without ICS
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 belongsOPRI Pte Ltd
Department/Research groupResearch in Real Life Ltd
Organisation/affiliationOPRI Pte Ltd
Website/Homepagewww.rirl.org
Details of (Primary) lead investigator
Title Miss
Last name Wood
First name Lucy
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 signed26/02/201505/03/2015
Start date of data collection07/04/201507/04/2015
Start date of data analysis07/04/201507/04/2015
Date of interim report, if expected12/05/201512/05/2015
Date of final study report30/05/201629/06/2016
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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