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 type:
  Non-interventional study
• Scope of the study:
  Other
• 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
• 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

• 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.
• 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.