Status: Finalised First registered on: 28/10/2014
Last updated on: 23/09/2020
1. Study identification
EU PAS Register NumberEUPAS7674
Official titleMultinational database cohort study to assess RMP-specified safety outcomes in association with indacaterol/glycopyrronium bromide in Europe
Study title acronym
Study typeObservational study
Brief description of the studyMultinational database cohort study to assess RMP-specified safety outcomes in association with indacaterol/glycopyrronium bromide in Europe
Was this study requested by a regulator?Yes: EMA
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 applicableCQVA149A2402
2. Research centres and Investigator details
Coordinating study entity
Centre nameNovartis Pharmaceuticals
Centre locationEast Hanover, NJ
Details of (Primary) lead investigator
Title Ms
Last name Novartis
First name Clinical Disclosure Officer
Is this study being carried out with the collaboration of a research network?
Yes
EU-ADR Alliance
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4

Aarhus University Dept. of Clinical Epidemiology
Health Search-SIMG
SIDIAP Jordi Gol, Spain
Countries in which this study is being conducted
International study

Denmark
Italy
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed17/12/2013
Start date of data collection01/11/2013
Start date of data analysis03/11/2014
Date of interim report, if expected20/02/2015
Date of final study report28/12/201803/12/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesNovartis Pharma AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Ms
Last name Novartis
First name Clinical Disclosure Office
Address line 1Novartis Pharma AG
Address line 2 
Address line 3 
CityBasel 
PostcodeCH-4002 
CountrySwitzerland
Phone number (incl. country code)41613241111 
Alternative phone number 
Fax number (incl. country code) 
Email address Trialandresults.registry@novartis.com
Public Enquiries
Title Ms 
Last name Novartis 
First name Clinical Disclosure Office 
Address line 1Novartis Pharma AG 
Address line 2 
Address line 3 
CityBasel 
PostcodeCH-4002 
CountrySwitzerland 
Phone number (incl. country code)41613241111 
Alternative phone number 
Fax number (incl. country code) 
Email address Trialandresults.registry@novartis.com 
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