An Australian based Study on the Patterns of Short Acting Beta-2 Agonist (SABA) use and Its Potential Effects on Asthma Control (SABINA Australia)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  Asthma

Population studied

• Age groups:
  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)
• Estimated number of subjects:
  21000

Study design details

• Main study objective:
  To determine the pattern and trend of SABA prescriptions in Australian asthma patients, selected in a cross-sectional manner as per the International SABINA program.
• Outcomes:
  Describe the demographic and clinical features of the asthma population Estimate SABA prescription per patient (by canisters per year) and describe the patients within the different SABA groups Estimate ICS and combination ICS/LABA prescription per patient and describe the patients within the different ICS groups, Describe the relation between SABA usage and number of severe exacerbations in the past 12 months per patient Describe the relation between SABA usage and asthma control (as defined by GINA). Describe the relation between SABA usage and number of OCS bursts in the past 12 months per patient.
• Data analysis plan:
  Demographic and clinical features of the asthma patients will be descriptively summarised. Additionally, descriptive analysis will be conducted by asthma severity, at each GINA step, for the overall population and for the regions. Summary statistics will be presented for primary variables overall. Further contingency tables will be generated for the three primary variables and prespecified categories of SABA prescription. Use SABA and ICS prescription per patient and describe patients within the different pre-specified categories of SABA authorisation. Summary statistics will be produced The association between the prespecified categories of SABA authorisation for patients with different disease severity defined by the GINA steps and health outcomes will be estimated. For each type of the health outcomes, model-based regression analyses for the overall population will be carried out and the confounders will be selected through stepwise forward selection.