Dose response curves for patients prescribed small & large particle ICS formulation: an observational evaluation of the comparative effect of ICS dose on asthma control achieved in real-life UK patients managed on extrafine hydrofluoroalkane beclomethasone, ciclesonide, fluticasone propionate, or Clenil

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  FLUTICASONE PROPIONATE

  BECLOMETASONE DIPROPIONATE

  CICLESONIDE
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Asthma patients prescribed small/large particle formulation of Inhaled corticosteroids (ICS).
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Asthma patients
• Estimated number of subjects:
  40000

Study design details

• Main study objective:
  The aim of the study was to evaluate the relationship between ICS dose and treatment outcomes for patients prescribed small / large particle formulation by comparing asthma control outcomes and treatment-related side effects associated with different doses of each ICS in order to create real-life dose-response curves.
• Outcomes:
  Dose-response curves were constructed over the one year outcome period to show patient response to prescribed ICS dose in terms of:• Increase in severe exacerbations• Increase in % predicted peak expiratory flow (PEF)• Increase in average daily SABA use. Characterise the real-life prescribing of each therapy during the outcome period.Characterise the real-life consumption of each therapy during the outcome period.
• Data analysis plan:
  Dose response curves (“Characteristics of Response” for initiation cohort) were plotted as error bar plots of:• Absolute change in severe exacerbation rate (ATS/ERS defined) from baseline to outcome versus ICS dose prescribed at IPD• Percentage change in severe exacerbation rate (ATS/ERS defined) from baseline to outcome versus ICS dose prescribed at IPD• Change in percent predicted PEF reading from baseline to outcome versus ICS dose prescribed at IPD• Change in average daily SABA use from baseline to outcome versus ICS dose prescribed at IPDThe ICS dose prescribed at IPD was categorised as appropriate for the patient sub-group (i.e. dependent on the frequency and spread of prescribed doses). The ICS dose prescribed may be logged.