The Role of Inhaler Device in the Treatment Persistence with Dual Bronchodilators in Patients with COPD

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Treatment persistence

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

  olodaterol and tiotropium bromide

  (R03AL03) vilanterol and umeclidinium bromide

  vilanterol and umeclidinium bromide
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Age groups:
  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  14719

Study design details

• Main study objective:
  The primary objective of the study is to use US claims data to determine relative treatment persistence in using Olodaterol/Tiotropium Bromide delivered with the Respimat soft mist inhaler and Umeclidinium/Vilanterol delivered with the Ellipta dry powder inhaler using a 1:2 propensity score matched analysis.
• Outcomes:
  The primary outcome of interest is discontinuation of index treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol), defined as persistence (i.e. no refill claim within 60 days not involving treatment switch, nor death (allowable grace period) after end of <n> days supply) during follow-up.
• Data analysis plan:
  Among the post-matched cohort, rates of discontinuation of Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol will be reported as the number of events divided by the number of person-years at risk.• Discontinuation of Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol in the Post-matched CohortAmong the post-matched cohort, risk (proportion of patients) of discontinuation of Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol will be reported as the number of events divided by the number of eligible patients at cohort entry date.