A Multinational Retrospective Medical Record Review to Evaluate Utilisation Patterns of ADASUVE® (Staccato loxapine for inhalation) in Agitated Persons in Routine Clinical Care

Study type

• Study type:
  Non-interventional study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N05AH01) loxapine

  loxapine

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  -To assess characteristics of patients in real world settings who are receiving ADASUVE® (including adherence to all aspects of SPC)-To assess characteristics of ADASUVE® prescribers, and care settings for whichADASUVE® is used in the post-authorisation period-To assess utilisation patterns for ADASUVE® (e.g. multiple doses, other medications to treat agitation, off-label use)
• Data analysis plan:
  Descriptive analyses will be performed. Summaries of continuous variables will include measures of central tendency (means, medians) and spread (standard deviation, range). The drug utilisation analysis will describe number of prescriptions broken down by prescribing department / medical specialty, indication for use, patient gender, patient age, severity of agitation and respiratory disease history. In addition, the indication for use will be further categorised as: Schizophrenia, Bipolar, and Other. Summaries of categorical orordinal variables will include counts, proportions, or percentages with 95% CIs.