CharacTeristics of treAtment response to hIgh dose ICS/LABA vs. Medium or high dOse ICS/LABA + LAMA in patients with uncontRolled moderate to severe asthma on medium dose ICS/LABA - TAILOR study

Study type

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

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (R03D) OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

  OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
• Medical condition to be studied:
  Asthma

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Estimated number of subjects:
  250000

Study design details

• Main study objective:
  • identify the main drivers of prescribing any of the three step-up treatment options (high dose ICS/LABA, medium dose ICS/LABA+LAMA, high dose ICS/LABA+LAMA) • What patient features/characteristics are associated with response to the specific treatment regimen
• Outcomes:
  Severe asthma exacerbations and effect on spirometry data, Use of health care resources Treatment patterns
• Data analysis plan:
  Descriptive statistical analyses, logistic regression and cluster analyses will be used. - Descriptive statistics to compare patients in the different treatment step-up cohorts (Main analysis 1) - Descriptive statistics to compare complete and partial responders and non-responders. - Identify determinants of response to each of the three step-up treatments by means of a logistic regression analysis. - Cluster analysis to describe phenotypes of patients responding to therapy - Analysis of change in healthcare resource utilisation (HCRU) and change in rescue medication by means of a Wilcoxon signed-rank test