Multinational, multi-database drug utilization study of indacaterol/glycopyrronium bromide in Europe

Study identification

• EU PAS number:
  EUPAS7795
• Study ID:
  39607
• Official title and acronym:
  Multinational, multi-database drug utilization study of indacaterol/glycopyrronium bromide in Europe
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Italy

  Netherlands

  Spain

  United Kingdom
• Study description:
  Multinational, multi-database drug utilization study of indacaterol/glycopyrronium bromide in Europe
• Study status:
  Finalised

Research institutions and networks

Institutions

Erasmus Medical Centre Rotterdam

Department of Medical Informatics - Health Data Science, Erasmus Medical Center (ErasmusMC)

Netherlands

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

Networks

EU-ADR Alliance

Study timelines

Date when funding contract was signed

Actual:17/12/2013

Study start date

Actual:01/11/2013

Data analysis start date

Planned:03/11/2014

Actual:11/03/2014

Date of interim report, if expected

Planned:02/02/2015

Date of final study report

Planned:31/10/2017

Actual:05/11/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma AG

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

CQVA149A2401