ICARUS: Inhaled Corticosteroid And Real life Unlicensed Spacer use – stage 2 (ICARUS 2)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  BECLOMETASONE PROPIONATE
• Medical condition to be studied:
  Asthma

Population studied

• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  To compare the number of inhaled corticosteroid related adverse events in patients prescribed aerochamber and volumatic spacers and non extra fine beclomethasone
• Outcomes:
  This is the number of adverse events by questionairre namely reported occurence of oral thrush OR hoarseness, These are database outcomes including evidence of osteoporosis, rash, swelling, glaucoma and adrenal failure in the outcome period
• Data analysis plan:
  The two groups will be compared for the number of adverse events using a Poisson regression model. Non inferiority will be achieved if the proportion of Aerochamber/beclomethasone adverse events (defined by oral thrush or hoarseness) is no more than 13% higher than volumatic/beclomethasone adverse events in the questionnaire returns