Status: Finalised First registered on: 08/02/2016
Last updated on: 10/10/2019
1. Study identification
EU PAS Register NumberEUPAS12330
Official titleAn observational evaluation of prescribing of fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist (ICS/LABA): fluticasone propionate / formoterol (FP/FOR) and adverse events in routine primary care at 18-months and 36-months post launch
Study title acronym
Study typeObservational study
Brief description of the studyThis study aims to evaluate adverse events, prescribing prevalence and patient characteristics for patients initiating on FP/FOR or other FDC ICS/LABA therapies prescribed in the 18 and 36 months post launch of FP/FOR in the UK. It will be a historical cohort study within which four subgroups will be evaluated (adult patients (≥ 12 years) with asthma, patients with COPD (and no asthma), paediatric asthma patients 4–11 years, patients prescribed ICS/LABA as the “MART” regimen). Patients included have ≥1 prescriptions for any ICS/LABA fixed-dose combination from 2012. The number and percentage of patients prescribed FP/FOR and other FDC ICS/LABAs and the frequency and percentage of adverse events and patient characteristics including demographic characteristics, comorbidities, medication and disease-severity measures will be evaluated for patients prescribed FP/FOR and other FDC ICS/LABA therapies, and for each of the subgroups.
Was this study requested by a regulator?Yes: United Kingdom
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
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.opri.sg
Details of (Primary) lead investigator
Title Miss
Last name Martin
First name Jessica
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 signed21/08/2014
Start date of data collection19/02/201624/06/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report12/09/201629/08/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMundipharma Research Ltd100
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 12 Changi Business Park Avenue 1
Address line 2Level 2 
Address line 3 
CitySingapore 
Postcode486015 
CountrySingapore
Phone number (incl. country code)6568097251 
Alternative phone number 
Fax number (incl. country code) 
Email address david@opri.sg
Public Enquiries
Title Professor 
Last name Price 
First name David 
Address line 12 Changi Business Park Avenue 1 
Address line 2Level 2 
Address line 3 
CitySingapore 
Postcode486015 
CountrySingapore 
Phone number (incl. country code)6568097251 
Alternative phone number 
Fax number (incl. country code) 
Email address david@opri.sg 
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