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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cross-sectional

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:
  Infants and toddlers (28 days – 23 months)

  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:
  20000

Study design details

• Main study objective:
  An exploratory study into the numbers of patients prescribed spacers with non extra fine beclomethasone for asthma in the UK
• Outcomes:
  Exploratory study into patient numbers using spacers in asthma with non extra fine beclomethasone
• Data analysis plan:
  The number and proportion of patients taking each spacer will be split by demographic characteristics and these will be presented in the final report