MulTinational database cohoRt study to assess adverse cardIovascular and cereBrovascular outcomes in patiEnts (TRIBE) with chronic obstructive pulmonary disease

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  FORMOTEROL FUMARATE DIHYDRATE

  GLYCOPYRRONIUM BROMIDE

  BECLOMETASONE DIPROPIONATE
• 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:
  25000

Study design details

• Main study objective:
  Investigate the incidence of adverse cardiovascular and cerebrovascular events among patients treated Fixed triple therapy containing beclometasone dipropionate, formoterol fumarate and glycopyrronium administered via DPI, compared with patients treated with Fixed triple therapy containing beclometasone dipropionate, formoterol fumarate and glycopyrronium administered via pMDI
• Outcomes:
  To assess the incidence of MACEs and compare it between Fixed triple therapy containing beclometasone dipropionate, formoterol fumarate and glycopyrronium DPI cohort and pMDI cohort. MACEs will be defined as any of the following events: Myocardial infarction, Stroke (ischemic and haemorrhagic stroke), Hospitalization due to acute coronary syndrome, Hospitalization due to heart failure, To assess the incidence of each of the following events individually: myocardial infarction, cerebrovascular disorders, hospitalization due to acute coronary syndrome, hospitalization due to heart failure, arrhythmia, and all-cause death.
• Data analysis plan:
  In the analysis, crude and adjusted incidence rates (95% CIs) of the composite primary outcome (MACE) and of each secondary outcome will be estimated seperately for new users of Fixed triple therapy containing beclometasone dipropionate, formoterol fumarate and glycopyrronium DPI (drug of interest) and Fixed triple therapy pMDI (comparator) for each data source. Exposure and follow-up time will be defined using an as-treated definition. Crude and adjusted incident rates will be computed using Poisson regression, for adjustment, weighted Poisson regression with inverse-probability-of-treatment weights based on propensity scores will be employed. Propensity scores will be estimated using a logistic regression model with demographic and lifestyle, health care utilization, COPD severity and other medical history variables as covariates. Pooled incidence rate ratio (IRR) estimates will be obtained by combining data-source level IRR estimates using a fixed-effects meta-analysis approach.