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

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Treatment persistence
• Data collection methods:
  Secondary use of data

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

• Short description of the study population:
  Patients with COPD
• 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:
  14.719

Study design details

• Study design:
  New-user cohort design with propensity scores used to match up to 2 Umeclidinium/Vilanterol initiators to each Olodaterol/Tiotropium Bromide initiator.
• 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.
• Setting:
  Data was utilized from Truven MarketScan claims database that captures longitudinal, individual-level administrative claims data from the United States. Patient identification period was between 17 November 2015 and 31 March 2018. ;
• 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.
• Summary results:
  The rate of discontinuation was 1,826 per 1,000 person-years in the Olo/Tio group compared to 1,647 per 1,000 person-years in the reference group resulting in a rate difference of appr. 179 per 1,000 person-years. ; The adjusted hazard ratio of discontinuation associated with Olo/Tio relative to Umec/Vi was 1.11 (95% CI: 1.06-1.16). Different sensitivity analyses did not have a meaningful impact on the results.