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 topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Tiotropium + Olodaterol
• 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:
  4.978

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.