Post-Authorisation Observational Study to Evaluate the Safety of ADASUVE® (Staccato loxapine for inhalation) in Agitated Persons in Routine Clinical Care

Study identification

• EU PAS number:
  EUPAS14236
• Study ID:
  26114
• Official title and acronym:
  Post-Authorisation Observational Study to Evaluate the Safety of ADASUVE® (Staccato loxapine for inhalation) in Agitated Persons in Routine Clinical Care
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Germany

  Romania

  Spain

  Sweden
• Study description:
  This is a multicenter, multinational, prospective observational study conducted in Europe to evaluate the safety of ADASUVE® when used in the routine clinical setting in agitated patients.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Ferrer Internacional

Study timelines

Date when funding contract was signed

Planned:14/01/2014

Actual:14/01/2014

Study start date

Planned:01/09/2014

Actual:16/07/2014

Date of final study report

Planned:31/07/2020

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Ferrer Internacional SA, Alexza Pharmaceuticals, Inc

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)