Safety profile of Tiotropium + Olodaterol used as maintenance treatment in COPD patients in Taiwan: a non-interventional study based on the Taiwan National Health Insurance (NHI) data (1237-0109)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Spiolto Respimat (Tiotropium + Olodaterol)
• Study drug International non-proprietary name (INN) or common name:
  OLODATEROL

  TIOTROPIUM
• Anatomical Therapeutic Chemical (ATC) code:
  (R03AL06) olodaterol and tiotropium bromide

  olodaterol and tiotropium bromide
• 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:
  4000

Study design details

• Main study objective:
  To estimate the incidence rate of safety outcomes in Chinese patients with COPD who initiated Tio/Olo
• Outcomes:
  Primary outcomes - Outcome type: Primary - Outcome Name: Incidence rate of adverse events in patients with COPD treated with Tio+Olo - Time Frame: 2014~2019 - Safety Issue (Yes/No): Yes, ; Secondary outcomes - Outcome type: Secondary - Outcome Name: Baseline characteristics of patients who initiated Tio+Olo or other LAMA/LABA - Time Frame: 2014~2019 - Safety Issue (Yes/No): No
• Data analysis plan:
  All variables, including patient characteristics, baseline measures, and outcomes, will be analysed 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, in which a >0.1 ASD indicates a meaningful difference. ; The standardized difference will be used as a parameter to quantify the between-group differences for each clinical attribute. This is metric is commonly used in studies utilizing secondary health data, in which a standardized difference of larger than 0.1 indicates a meaningful difference with respect to the clinical attribute between the two study groups.