Status: Finalised First registered on: 07/11/2017
Last updated on: 19/09/2022
1. Study identification
EU PAS Register NumberEUPAS21574
Official titleCohort study of cardiovascular events in patients with chronic obstructive pulmonary disease initiating olodaterol or other long-acting beta2-agonists
Study title acronym
Study typeObservational study
Brief description of the studyBoehringer Ingelheim GmbH (BI) developed olodaterol, an inhaled long-acting beta2-agonist (LABA), for the indication of chronic obstructive pulmonary disease (COPD). In the Decentralised Procedure for Striverdi Respimat, the health authorities of the European Union/European Economic Area Member States requested the conduct of a post-authorisation safety study (PASS) to gather additional data on safety in long-term use of olodaterol. The PASS will include evaluation of users of olodaterol monotherapy as well as in fixed-dose combination with tiotropium. The results of this study will provide insight into the absolute and relative frequency of cardiac arrhythmias and myocardial ischaemia events of interest in comparison to alternative LABA therapies for COPD. Primary study objectives are to: (1) examine the risk of selected cardiac arrhythmias in patients with COPD exposed to olodaterol compared with the risk in patients exposed to other LABAs, and (2) examine the risk of acute myocardial infarction (AMI) and other serious ischaemic heart disease events, including unstable angina, in patients with COPD exposed to olodaterol compared with the risk in patients exposed to other LABAs. The secondary objective is to examine the risk of overall mortality in patients with COPD exposed to olodaterol compared with the risk in patients exposed to other LABAs. The study population will consist of patients with COPD aged 40 years or older in Denmark, a country where olodaterol is available and where a large proportion of the population is included in health care databases used for pharmacoepidemiologic research. Patients will be new users of olodaterol or other LABA, with no dispensing of any LABA in the 6 months before the first prescription of olodaterol or LABA during the study period (index date) and at least 1 year of enrolment in the database.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 2 (specific obligation of marketing authorisation)
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 belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagehttps://www.rtihs.org/services/pharmacoepidemiology-and-risk-management
Details of (Primary) lead investigator
Title Dr
Last name Rebordosa
First name Cristina
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2

Aarhus University Dept. of Clinical Epidemiology
RTI-HS
Countries in which this study is being conducted
National study

Denmark
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed18/08/201518/08/2015
Start date of data collection31/03/202015/07/2019
Start date of data analysis01/07/202003/02/2020
Date of interim report, if expected
Date of final study report30/09/202015/09/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBoehringer Ingelheim International GmbH100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Rebordosa
First name Cristina
Address line 1Av. Diagonal, 605, 9-1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08024 
CountrySpain
Phone number (incl. country code)34933622807 
Alternative phone number 
Fax number (incl. country code)34937608507 
Email address crebordosa@rti.org
Public Enquiries
Title Dr 
Last name Rebordosa 
First name Cristina 
Address line 1Av. Diagonal, 605, 9-1 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08024 
CountrySpain 
Phone number (incl. country code)34933622807 
Alternative phone number 
Fax number (incl. country code)34937608507 
Email address crebordosa@rti.org 
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