Prospective Case-Control Safety Study of Bronchitol (inhaled mannitol) in Patients with Cystic Fibrosis from the UK CF Registry

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33911
• EU PAS number:
  EUPAS20668
• Study ID:
  33911
• Official title and acronym:
  Prospective Case-Control Safety Study of Bronchitol (inhaled mannitol) in Patients with Cystic Fibrosis from the UK CF Registry
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Post-authorisation safety study is being conducted pursuant to an obligation imposed by the EMA as a condition of the granting of a marketing authorisation for Bronchitol (mannitol) to confirm the safety profile of Bronchitol, identify, characterise and/or quantify any emergent safety issues, and measure the effectiveness of agreed risk management strategies.
• Study status:
  Finalised

Research institutions and networks

Institutions

Cystic Fibrosis Trust

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 29/06/2012

Actual: 29/06/2012

Study start date

Planned: 01/07/2012

Actual: 01/07/2012

Date of final study report

Planned: 30/04/2018

Actual: 05/11/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pharmaxis Ltd

Study protocol

Initial protocol

Registry Study Protocol V1.0 Final

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 2 (specific obligation of marketing authorisation)