Health Care Resource Utilization, Cost and Other Outcomes of Patients Diagnosed with COPD Initiating Tiotropium Bromide/Olodaterol versus Fluticasone Furoate/Umeclidinium/Vilanterol

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Healthcare resource utilisation

  Other

  Safety study (incl. comparative)
• If ‘other’, further details on the scope of the study:
  Comparative real world outcomes study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  TIOTROPIUM BROMIDE

  OLODATEROL

  FLUTICASONE FUROATE

  UMECLIDINIUM

  VILANTEROL TRIFENATATE
• 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:
  11316

Study design details

• Study design:
  This was a non-interventional study using existing data from commercial enrollees and Medicare Advantage with Part D beneficiaries diagnosed with COPD who initiated treatment with TIO/OLO or FF/UMEC/VI. The study period was from 01 June 2014 through 31 December 2019.
• Main study objective:
  The purpose of this study is to estimate disease-related and all-cause burden and clinical outcomes of interest following initiation of COPD maintenance therapy with TIO/OLO or FF/UMEC/VI.
• Comparators:
  Newly treated with TIO/OLO compared with patients newly treated with FF/UMEC/VI.
• Outcomes:
  COPD and/or pneumonia-related total costs, COPD and/or pneumonia-related medical costs COPD and/or pneumonia-related pharmacy costs COPD and/or pneumonia-related inpatient visits COPD and/or pneumonia-related emergency department visits COPD and/or pneumonia-related ambulatory visits COPD and/or pneumonia-related other medical visits COPD exacerbations Severe COPD exacerbations Pneumonia or bronchitis/bronchitis
• Data analysis plan:
  Stratified propensity score matching, using an exact match on exacerbation history and maintenance naive status followed by a propensity score match on baseline characteristics, to control for possible confounding of the association between the treatment (TIO/OLO or FF/UMEC/VI) and outcomes (e.g. health care resource utilization). Outcomes will be reported as population annualized averages for each cohort to account for the variable follow-up duration.