Does the cost of inhaler devices affect therapy adherence and disease outcomes?

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Irish primary care population diagnosed with asthma/COPD with ≥ 1 prescription for SABA (short-acting beta2-agonist)/SAMA (short-acting muscarinic antagonist), LABA (long-acting beta2-agonist)/LAMA (long-acting muscarinic antagonist) or ICS (inhaled corticosteroids) prior to the index date.
• 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)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  150

Study design details

• Main study objective:
  To find if free prescriptions influences adherence to asthma and COPD treatment
• Outcomes:
  Adherence to maintenance asthma and COPD therapy, Risk domain asthma controlNumber of severe exacerbationsAcute respiratory eventsSABA reliever usage
• Data analysis plan:
  Baseline differences across the study cohorts will be analysed to look for differencesThe proportion of patients who are considered adherent (>80% refill rate) will be compared between the free prescription and the paying group. A difference of 25% will be considered significant.Secondary outcomes will be compared using chi square and wilcoxon tests as appropriate.