Effectiveness and Safety of Maintenance Treatment with Combination of Tiotropium and Olodaterol in comparison to Maintenance Treatment with a Combination of Inhaled Corticosteroids, Long-acting β2 Agonists and Long-acting Muscarinic Antagonists in COPD Patients

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

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

  (R03AA) Alpha- and beta-adrenoreceptor agonists

  Alpha- and beta-adrenoreceptor agonists

  (R03B) OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS

  OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
• 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:
  4000

Study design details

• Main study objective:
  The primary objective is to compare the effectiveness of new use of maintenance therapy initiation with the combination treatment Tiotropium and Olodaterol (Tio+Olo) compared with new use of LABA/LAMA/ICS combination in COPD as the time to the first COPD exacerbation
• Outcomes:
  Severe exacerbation as hospitalization with a principal discharge diagnosis of COPD.Moderate exacerbation defined as ED visit with a discharge diagnosis of COPD and/or dispensing of an antibiotic and an oral corticosteroid on the same day
• Data analysis plan:
  Patient characteristics at baseline in patients treated with Tio+Olo and patients treated with LABA/LAMA/ICS will be described using standard descriptive statistics. High-dimensional propensity scores including both pre-specified and data-derived variables will then be calculated. We will use fine stratification and reweighting of the exposure propensity score to control for measured covariates. Cox proportional hazard regression model will be used to perform an as-treated analysis that assesses the effect of current use of LABA-LAMA-ICS combination versus the Tio+Olo combination on the risk of a first COPD exacerbation. It will provide an estimate of the hazard ratio (HR) of a COPD exacerbation associated with LABA-LAMA-ICS use relative to Tio+Olo use, along with 95% confidence intervals (CI).