Modified Prescription-Event Monitoring Study to Monitor the Introduction of Atrovent Inhaler CFC-Free® MDI in the United Kingdom (Atrovent CFC-free M-PEM)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/6353
• EU PAS number:
  EUPAS6352
• Study ID:
  6353
• Official title and acronym:
  Modified Prescription-Event Monitoring Study to Monitor the Introduction of Atrovent Inhaler CFC-Free® MDI in the United Kingdom (Atrovent CFC-free M-PEM)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This was a modified prescription event monitoring (M-PEM) study to monitor the safety of Atrovent® CFC-free MDI following a switch from CFC-containing propellants. M-PEM is a non-interventional prospective observational study methodology. The exposure data comprise information from prescriptions collected by the NHS Business Services Authority (NHSBSA) in England. The outcome data are event reports during three month pre- and post-exposure periods, obtained by sending questionnaires to the general practitioners (GPs) who issued prescriptions for Atrovent® CFC-free MDI.
• Study status:
  Finalised

Research institution and networks

Institutions

Drug Safety Research Unit (DSRU)

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 05/05/2004

Study start date

Actual: 06/05/2004

Date of final study report

Actual: 06/07/2010

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable