Inhaler adherence and time to GINA step 5 therapy in a real-life moderate to severe asthma population

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• 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

• Anatomical Therapeutic Chemical (ATC) code:
  (R03AK06) salmeterol and fluticasone

  salmeterol and fluticasone

  (R03AK07) formoterol and budesonide

  formoterol and budesonide

  (R03AK07) formoterol and budesonide

  formoterol and budesonide

  (R03AK10) vilanterol and fluticasone furoate

  vilanterol and fluticasone furoate

  (R03AK11) formoterol and fluticasone

  formoterol and fluticasone
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Asthma patients initiating inhaled corticosteroids and long-acting beta agonists in fixed dose combinations (ICS/LABA FDC).; ; Inclusion criteria are:; 1. New user with a dispensed prescription of an ICS/LABA FDC product (defined as no dispensings of ICS/LABA FDC during the preceding 1 year); 2. At least one year of follow-up data available after the index date; 3. At least one more ICS/LABA FDC dispensing (excluding index ICS/LABA FDC prescription) within one year after prescription at index date; 4. ≥ 12 years and <45 years old at index date; 5. At least 2 other respiratory dispensings (not being ICS/LABA FDC or GINA step 5 treatments) in the year before index date (i.e. any dispensings of single short-acting beta agonists (R03AC02, R03AC03, R03AK04, R03CC02, R03CC03), short-acting muscarinic antagonists (R03BB01), inhaled corticosteroids (R03BA), cromones; (R03BC), xanthines (R03DA), or leukotriene antagonists (R03DC))
• Age groups:
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Asthma patients
• Estimated number of subjects:
  3500

Study design details

• Main study objective:
  To assess the rates and time to GINA step 5 therapy in asthma patients initiating ICS/LABA in fixed dose combinations (ICS/LABA FDC) and assess the impact of different inhaler adherence trajectories.
• Outcomes:
  The primary outcome of this study is the percentage of patients on ICS/LABA FDC that received GINA step 5 treatment, defined as any dispense of either (1) low dose OCS, (2) biologicals: omalizumab, mepolizumab, benralizumab or (3) LAMA. Total number of GINA step 5 step-ups (combined, and per subgroup of OCS, biological or LAMA and adherence trajectory) over the complete follow-up. Other secondary outcome is the time to GINA step 5 treatment.
• Data analysis plan:
  Patient characteristics will be described using descriptive statistics. Categorical variables will be described by frequencies and percentages. Continuous variables will be described using mean (± standard deviation SD) for normally distributed data or median and interquartile range (IQR) for skewed distributions. Adherence to ICS/LABA FDC will be calculated using group-based trajectory modeling (GBTM) over a 1-year period after the index date. Hazard ratios for time to GINA step 5 therapy and corresponding 95% confidence intervals will be assessed using Cox proportional hazards models. Kaplan-Meier plots will be examined to check the fulfillment of proportional hazards assumption.