Status: Finalised First registered on: 15/04/2014
Last updated on: 16/04/2014
1. Study identification
EU PAS Register NumberEUPAS6352
Official titleModified Prescription-Event Monitoring Study to Monitor the Introduction of Atrovent Inhaler CFC-Free® MDI in the United Kingdom
Study title acronymAtrovent CFC-free M-PEM
Study typeObservational study
Brief description of the studyThis was a modified prescription event monitoring (M-PEM) study to monitor the safety of Atrovent® CFC-free MDI following a switch from CFC-containing propellants. M-PEM is a non-interventional prospective observational study methodology. The exposure data comprise information from prescriptions collected by the NHS Business Services Authority (NHSBSA) in England. The outcome data are event reports during three month pre- and post-exposure periods, obtained by sending questionnaires to the general practitioners (GPs) who issued prescriptions for Atrovent® CFC-free MDI.
Was this study requested by a regulator?Yes: United Kingdom
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 belongsDSRU
Department/Research group
Organisation/affiliationDrug Safety Research Unit
Website/Homepagewww.dsru.org
Details of (Primary) lead investigator
Title Professor
Last name Shakir
First name Saad
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 signed05/05/2004
Start date of data collection06/05/2004
Start date of data analysis
Date of interim report, if expected
Date of final study report06/07/2010
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBoehringer Ingelheim100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Shakir
First name Saad
Address line 1DSRU
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom
Phone number (incl. country code)44-2380-408600 
Alternative phone number 
Fax number (incl. country code)44-2380-408609 
Email address saad.shakir@dsru.org
Public Enquiries
Title Professor 
Last name Shakir 
First name Saad 
Address line 1DSRU 
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom 
Phone number (incl. country code)44-2380-408600 
Alternative phone number 
Fax number (incl. country code)44-2380-408609 
Email address saad.shakir@dsru.org 
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