Status: Finalised First registered on: 23/10/2014
Last updated on: 17/11/2020
1. Study identification
EU PAS Register NumberEUPAS7761
Official titleWWE117397: Post-authorization safety Electronic Medical Records database retrospective cohort study of new users of inhaled UMEC/VI or new users of inhaled UMEC in the primary care setting: UK EMR distributed network study
Study title acronym
Study typeObservational study
Brief description of the studyThis study primarily aims to collect data reflecting the real-world experience with UMEC/VI and UMEC in the post-approval setting (period of up to 24 months from the start of UMEC/VI and UMEC availability in the United Kingdom). The study will use a retrospective longitudinal non-interventional observational study design to identify patients based on a new prescription (index prescription date) for UMEC/VI, UMEC, or other long acting bronchodilators (LABD). These patients will be followed-up from their index prescription date until censoring at death, leaving practice, or end of follow-up at 30 June 2017.
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 belongsCPRD
Department/Research group
Organisation/affiliationClinical Practice Research Datalink
Website/Homepagewww.cprd.com
Details of (Primary) lead investigator
Title Mr
Last name Dedman
First name Daniel
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 signed04/06/201404/06/2014
Start date of data collection01/03/201501/03/2015
Start date of data analysis
Date of interim report, if expected31/03/2017
Date of final study report31/12/201910/12/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesGlaxoSmithKline100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mr
Last name Dedman
First name Daniel
Address line 1151 Buckingham Palace Road
Address line 2 
Address line 3 
CityLondon 
PostcodeSW1W 9SZ 
CountryUnited Kingdom
Phone number (incl. country code)44-203-0806383 
Alternative phone number 
Fax number (incl. country code)44-203-1189802 
Email address cdr_mailbox@gsk.com
Public Enquiries
Title Mr 
Last name Dedman 
First name Daniel 
Address line 1151 Buckingham Palace Road 
Address line 2 
Address line 3 
CityLondon 
PostcodeSW1W 9SZ 
CountryUnited Kingdom 
Phone number (incl. country code)44-203-0806383 
Alternative phone number 
Fax number (incl. country code)44-203-1189802 
Email address cdr_mailbox@gsk.com 
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