Post-authorisation Safety (PAS) Observational Cohort Study to Quantify the Incidence and Comparative Safety of Selected Cardiovascular and Cerebrovascular Events in COPD Patients Using Inhaled UMEC/VI Combination or Inhaled UMEC versus Tiotropium (Study 201038)

Study type

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

  Effectiveness study (incl. comparative)

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 MONOHYDRATE

  UMECLIDINIUM BROMIDE

  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)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  7214

Study design details

• Main study objective:
  The primary objectives are: 1. To demonstrate non-inferiority of UMEC/VI combination and UMEC to tiotropium for risk of myocardial infarction (MI), stroke, heart failure or sudden cardiac death based on analysis to time to first event. 2. To quantify incidence rate and frequency of MI, stroke, heart
• Outcomes:
  Safety outcomes reported will include MI, stroke and new onset, or acute worsening/decompensation heart failure, sudden cardiac death, serious pneumonia/serious LRTI events, all-cause mortality, CV mortality and non-CV mortality, haemorrhagic stroke and ischaemic stroke, hospitalisation for heart failure, SAEs, all serious CV AESIs and all drug related AEs. Treatment effectiveness outcomes recorded will include persistence with initiated medications, moderate/severe COPD exacerbations (requiring treatment with one or more of the following: antibiotics, systemic steroids, hospitalisation) and health care utilisation: all cause and COPD-related.
• Data analysis plan:
  The analysis will compare new users of UMEC/VI with new users of tiotropium, and new users of UMEC with new users of tiotropium. These new treatments may be added on to existing therapies. Analyses will be based on the time to the first event of stroke, MI and heart failure individually and non-inferiority will be considered to be demonstrated if the upper bound of the 95% confidence interval around the hazard ratio is 2.0 or less. If the lower bound is greater than 1.0, non-inferiority will not be assumed.

Documents

Study report

Clinical Study Report Anonymized 29 Jan 2024.pdf