Inhaled Corticosteroid and Real Life unlicensed Spacer Use (stage 1) (ICARUS 1)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/13186
• EU PAS number:
  EUPAS13185
• Study ID:
  13186
• Official title and acronym:
  Inhaled Corticosteroid and Real Life unlicensed Spacer Use (stage 1) (ICARUS 1)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Examining the real-life unlicensed and licensed use of inhaled corticosteroids with or without spacers in patients with asthma in the United Kingdom
• Study status:
  Planned

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 18/04/2016

Study start date

Planned: 09/05/2016

Data analysis start date

Planned: 10/05/2016

Date of interim report, if expected

Planned: 06/06/2016

Date of final study report

Planned: 31/08/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

chiesi

Study protocol

Initial protocol

20160416_R00616_Chiesi_ICARUS_protocol_stage1_v0.4

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable