Comparison of Exacerbation Risk and Health Outcomes in Maintenance Treatment Naïve COPD patients using Stiolto vs. Trelegy

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

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

• Short description of the study population:
  Patients with chronic obstructive pulmonary disease received treatment with tiotropium/olodaterol or fluticasone furoate/umeclidinium/vilanterol.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with chronic obstructive pulmonary disease
• Estimated number of subjects:
  5902

Study design details

• Main study objective:
  The goal of this study was to investigate the risk of COPD exacerbations, community acquired pneumonia, and health care utilization and costs in maintenance treatment naïve patients treated as first line therapy with TIO/OLO, in comparison to maintenance treatment naïve patients treated with first line therapy, FF/UMEC/VI
• Outcomes:
  Time to first COPD exacerbation (moderate/severe) Rate of moderate and/or severe exacerbation, Time to first hospitalization of community acquired pneumonia COPD and/or pneumonia-related health care resource utilization COPD and/or pneumonia-related health care resource utilization costs All cause health care resource utilization All cause health care resource utilization costs
• Data analysis plan:
  Propensity score matching 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.