Status: Finalised First registered on: 24/01/2017
Last updated on: 21/01/2020
1. Study identification
EU PAS Register NumberEUPAS17386
Official titleDrug Utilisation Study for Olodaterol
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). Because the use of LABAs has been associated with increased morbidity and mortality in patients with asthma, the health authorities requested the conduct of a post-approval drug utilisation study to assess potential off-label use of olodaterol in asthma and to characterise the use of olodaterol in clinical practice. The single agent indacaterol, the only other marketed LABA authorised in clinical practice for COPD but not for asthma, will also be assessed. Study objectives include the following: (1) Quantify the frequency of off-label use of olodaterol and indacaterol among new users of these medications; and (2) Describe the baseline characteristics of new users of olodaterol and indacaterol. This cross-sectional study will use information among new users of olodaterol or indacaterol collected in the following healthcare databases: the PHARMO Database Network in the Netherlands, the National Registers in Denmark, and the IMS Health Information Solutions (IMS) Real-World Evidence (RWE) Longitudinal Patient Database (LPD) in France. The source population is all subjects enrolled in the selected study databases at the date olodaterol became available in each database’s country. The study groups are those subjects from the source population who receive a first dispensing for single-agent formulations of olodaterol for the primary objective or indacaterol for the secondary objective and have at least 12 months of continuous enrolment in the study databases. The study will describe the number and proportion of new users by indication and potential off-label use and according to medical history and use of co-medications.
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 Gilsenan
First name Alicia
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?4

IMS Health
PHARMO Institute
Aarhus University Dept. of Clinical Epidemiology
RTI-HS
Countries in which this study is being conducted
International study

Denmark
France
Netherlands
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 collection01/02/201712/01/2017
Start date of data analysis08/02/2017
Date of interim report, if expected01/09/201723/08/2017
Date of final study report30/09/201803/09/2018
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 Gilsenan
First name Alicia
Address line 1200 Park Offices Dr
Address line 2 
Address line 3 
CityResearch Triangle Park 
Postcode27709 
CountryUnited States
Phone number (incl. country code)19195418745 
Alternative phone number 
Fax number (incl. country code)19195416630 
Email address agilsenan@rti.org
Public Enquiries
Title Dr 
Last name Gilsenan 
First name Alicia 
Address line 1200 Park Offices Dr 
Address line 2 
Address line 3 
CityResearch Triangle Park 
Postcode27709 
CountryUnited States 
Phone number (incl. country code)19195418745 
Alternative phone number 
Fax number (incl. country code)19195416630 
Email address agilsenan@rti.org 
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