Early Intervention Efficacy of Tiotropium/Olodaterol Compared to Tiotropium in Chronic Obstructive Pulmonary Disease (COPD) (Early Intervention Efficacy in COPD)

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:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  1856

Study design details

• Main study objective:
  To evaluate the time to escalation to triple therapy among the Japanese Chronic obstructive pulmonary disease (COPD) patients newly initiating therapy with a combination of Olodaterol and Tiotropium (herein referred to as Tio/Olo) using real world data.
• Outcomes:
  Time to Long-Acting Muscarinic Antagonists (LAMA)/Long-Acting Beta-Agonists (LABA)/Inhaled Corticosteroid (ICS) triple therapy initiation among initiators of Tio/Olo vs. initiators of Tio, Time to First Moderate or Severe COPD ExacerbationsNumber of Moderate or Severe COPD Exacerbations
• Data analysis plan:
  For demographic and lifestyle variables, the value recorded on the cohort entry date will be reported, otherwise the most recent known value will be reported. Presence of comorbidities and use of concomitant medication use will be determined based on whether they ever occurred within the 180-day baseline period preceding the index date. Rates of triple therapy use for each treatment group will be reported as the number of events divided by the total number of person-years at risk during follow-up. Risk of triple therapy for each treatment group will be reported as the number of events divided by the total number of patients at risk. Among both the basic propensity score matched and high dimensional propensity score matched cohort, Cox regression will be used to estimate the hazard ratios and 95% CI for Tiotropium/Olodaterol compared to patients treated with Tiotropium during follow-up for time-to-first triple therapy initiation using an intention-to-treat censoring approach.