Effectiveness of Maintenance Treatment with Tiotropium + Olodaterol in Comparison to Inhaled Corticosteroids + Long-acting β2 agonists in COPD patients in Taiwan: a non-interventional study based on the Taiwan National Health Insurance (NHI) data. (1237-0110)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Chronic obstructive pulmonary disease

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:
  4978

Study design details

• Main study objective:
  To compare time to the first moderate or severe COPD exacerbations between initiators of Tio/Olo and ICS/LABA in a real world setting.
• Outcomes:
  Primary outcomes - Outcome type: Primary - Outcome Name:Time to the first moderate or severe COPD exacerbations after index date - Time Frame: 2014~2019 - Safety Issue (Yes/No): No, Secondary outcomes Time to triple therapy escalation after index date,Incidence rate of triple therapy initiation (first event per patient),Time to the first hospitalization for community-acquired,Annualized rate of prescriptions of rescue medications after the index date,Annualized rate of moderate or severe COPD exacerbation after the index date Time Frame: 2014~2019
• Data analysis plan:
  All variables, including patient characteristics, baseline measures, and outcomes, will be analyzed descriptively. For all analyses, variables will be reported as follows: Continuous variables (e.g. age) will be presented as means (with standard deviation, SD) and/or medians (with interquartile range, IQR), minimum, maximum. Categorical variables (e.g. sex) will be presented as absolute and relative frequencies. Absolute standardized differences (ASDs) will be used to compare the characteristics between the two groups after propensity score matching, in which a >0.1 ASD indicates a meaningful difference.