Status: Finalised First registered on: 23/10/2014
Last updated on: 24/03/2015
1. Study identification
EU PAS Register NumberEUPAS7753
Official titleComparative effectiveness and safety of Ipramol (ipratropium/albuterol) SteriNebs® vs. DuoNeb®
Study title acronym
Study typeObservational study
Brief description of the studyHistoric cohort, US database study comparing effectiveness and safety of nebulised COPD medication labelled by Teva Ltd (Ipramol SteriNebs®) against the originator product (DuoNeb®)
Was this study requested by a regulator?Don't know
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 belongsRIRL
Department/Research group
Organisation/affiliationResearch in Real Life Ltd.
Website/Homepagewww.rirl.org
Details of (Primary) lead investigator
Title Dr
Last name Mares
First name Rafael
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 States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed07/05/201407/05/2014
Start date of data collection30/06/201407/07/2014
Start date of data analysis15/08/201419/09/2014
Date of interim report, if expected14/10/201414/10/2014
Date of final study report03/11/201403/11/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTeva100
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 116 Raffles Quay
Address line 2#33-03 
Address line 3Hong Leong Building 
CitySingapore 
Postcode048581 
CountrySingapore
Phone number (incl. country code)44-1223-967829 
Alternative phone number 
Fax number (incl. country code) 
Email address david@rirl.org
Public Enquiries
Title Professor 
Last name Price 
First name David 
Address line 116 Raffles Quay 
Address line 2#33-03 
Address line 3Hong Leong Building 
CitySingapore 
Postcode048581 
CountrySingapore 
Phone number (incl. country code)44-1223-967829 
Alternative phone number 
Fax number (incl. country code) 
Email address david@rirl.org 
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