Long-Term Post-Marketing Observational Study of the Safety of Roflumilast

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50538
• EU PAS number:
  EUPAS14852
• Study ID:
  50538
• Official title and acronym:
  Long-Term Post-Marketing Observational Study of the Safety of Roflumilast
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Norway

  Sweden

  United States
• Study description:
  Chronic 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Real World Solutions, IQVIA

Netherlands

United Kingdom (Northern Ireland)

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

Epi Research Oy Finland, Quintiles Real World and Late Phase Research (RWLPR), EMR Data and Analytics USA

Study timelines

Date when funding contract was signed

Actual: 01/07/2010

Study start date

Planned: 13/10/2013

Actual: 30/03/2013

Data analysis start date

Planned: 31/01/2020

Actual: 30/03/2013

Date of interim report, if expected

Planned: 31/10/2017

Actual: 31/10/2017

Date of final study report

Planned: 31/12/2022

Actual: 16/12/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Study protocol

Initial protocol

RO-2455-403-RD_ProtocolVersion2.4-31Jul13

Updated protocol

D7120R00003_ProtocolVersion3_updated20170207

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)
• Regulatory procedure number:
  D7120R00003

Other study registration identification numbers and links

D7120R00003