Status: Ongoing First registered on: 19/08/2016
Last updated on: 08/12/2017
1. Study identification
EU PAS Register NumberEUPAS14852
Official titleLong-Term Post-Marketing Observational Study of the Safety of Roflumilast
Study title acronym
Study typeOther: Postmarketing Safety Study
Brief description of the studyChronic obstructive pulmonary disease (COPD) is a leading cause of death. Takeda Development Centre (Europe) Ltd (formerly Nycomed) received central marketing authorization in the EU in July 2010 and regulatory approval in Canada in November 2010 for its selective phosphodiesterase-4 (PDE4) inhibitor roflumilast (DAXAS®), which is available as 500µg tablets (once daily) for maintenance treatment of severe COPD associated with chronic bronchitis in adults with a history of frequent exacerbations as add on to bronchodilator treatment. Roflumilast is contraindicated in patients with hypersensitivity to the tablet ingredients and in patients with moderate to severe liver impairment. Since roflumilast is used for maintenance treatment, a long-term safety assessment exceeding 12 months was requested as a condition of approval for marketing in the EU. During the approval process, Takeda as the Marketing Authorisation Holder (MAH) for roflumilast, committed to the European Medicines Agency (EMA) to perform a database study, and proposed that the study be conducted in large, unselected COPD populations, reflecting the use of roflumilast in a real-life setting. Established electronic health care databases in countries where roflumilast is on the market and data on a meaningful number of roflumilast treated patients is captured will be the source on which to base this Post-Authorisation Safety Study (PASS). Due to the sponsorship transfer that occurred in 2015, study is now sponsored by AstraZeneca. The study is conducted by independent investigators qualified in epidemiology. The patient data will remain the properties of the respective database owners, and AstraZeneca will not have direct access to the data but will be co-owner of the results derived from these data, together with the respective investigators. The Lead Investigator will lead the team of investigators, each of whom is responsible for the conduct of the study.
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 applicableD7120R00003
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBIPS GmbH
Department/Research groupClinical Epidemiology
Organisation/affiliationLeibniz Inst. for Prevention Research and Epidem.
Website/Homepagewww.bips.eu
Details of (Primary) lead investigator
Title Professor
Last name Garbe
First name Edeltraud
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?3

BIPS GmbH
Epi Research Oy, Finland
Quintiles Real World and Late Phase Research (RWLPR), EMR Data and Analytics, USA
Countries in which this study is being conducted
International study

Germany
Sweden
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/07/2010
Start date of data collection30/03/2013
Start date of data analysis31/01/2020
Date of interim report, if expected31/10/201731/10/2017
Date of final study report31/03/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Garbe
First name Edeltraud
Address line 11800 Concord Pike, PO Box 15437
Address line 2 
Address line 3 
CityWilmington, De 
Postcode19850 
CountryUnited States
Phone number (incl. country code)0018772409479 
Alternative phone number 
Fax number (incl. country code)0018772409479 
Email address information.center@astrazeneca.com
Public Enquiries
Title Dr 
Last name AstraZeneca 
First name Clinical Study Information Center 
Address line 11800 Concord Pike, PO Box 15437 
Address line 2 
Address line 3 
CityWilmington, De 
Postcode19850 
CountryUnited States 
Phone number (incl. country code)0018772409479 
Alternative phone number 
Fax number (incl. country code)0018772409479 
Email address information.center@astrazeneca.com 
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