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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective Observational 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:
  1500

Study design details

• Main study objective:
  To assess the frequency and nature (e.g. severity) of AEs, with a primary focus on serious adverse events (SAEs) and AESIs, including respiratory events following the administration of ADASUVE® in real world settings.
• Outcomes:
  Incidence of respiratoty AESIs, including bronchospasm-related AEs, Incidence of other ( non respiratory) AESIs:hypotensionExtrapyramidal symptomsNeuroleptic malignant síndrome/rhabdomyolysisseizures
• 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). Summaries of categorical or ordinal variables will include counts, proportions or percentages with 95% CIs. The primary safety analysis will examine the frequency and percentage of patients experiencing SAEs, AESIs (e.g. respiratory AEs) associated with ADASUVE® treatment. AEs will be characterized according to their severity and outcome. All AE verbatim terms will be recorded and coded using Medical Dictionary for Regulatory Activities (MedDRA). The AE rates will be computed for all study patients combined and also for meaningful subgroups of patients