GSK COPD

• Research type

  Research Study

• Full title

  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).

• IRAS ID

  193091

• Contact name

  John Hurst

• Contact email

  j.hurst@ucl.ac.uk

• Sponsor organisation

  GlaxoSmithKline PLC

• Duration of Study in the UK

  5 years, 11 months, 2 days

• Research summary

  This is a prospective observational study which aims to collect data reflecting the ‘real-world’ experience of Chronic Obstructive Pulmonary Disease (COPD) patients treated with either umeclidinium (UMEC; long-acting muscarinic antagonist [LAMA])/vilanterol (VI; longacting beta2 agonist [LABA]) combination product or UMEC in the post approval setting.
  The purpose of the study is to expand understanding of the potential cardiovascular (CV) and cerebrovascular risks of heart attacks (also known as myocardial infarction (MI)), stroke and new onset or acute worsening/decompensation heart failure of UMEC/VI and UMEC as compared to tiotropium. Tiotropium is a LAMA with a well established safety and efficacy profile.
  The Pharmacovigilance Risk Assessment Committee (PRAC) accepted the proposed
  study summary and the European Commission confirmed the obligation to perform the
  study as a condition of the European licenses for UMEC/VI and UMEC.

  This bservational cohort study of COPD patients designed to
  demonstrate non-inferiority for each of the three individual Cardiovascular and cerebrovascular outcomes of MI, stroke and new onset, or acute worsening/decompensation heart failure.
  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, Myocardial Infarction 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.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  16/SC/0023

• Date of REC Opinion

  31 Mar 2016

• REC opinion

  Further Information Favourable Opinion