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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/107565
• EU PAS number:
  EUPAS10316
• Study ID:
  107565
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Czechia

  Germany

  Hungary

  Italy

  Netherlands

  Poland

  Spain

  United Kingdom

  United States
• Study description:
  The study will address the research question of whether the incidence rates of cardiovascular (CV) and cerebrovascular events differ for new users of umeclidinium bromide/vilanterol trifenatate (UMEC/VI) combination or umeclidinium bromide (UMEC) compared with tiotropium in patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
• Study status:
  Ongoing

Research institution and networks

Institutions

Quintiles

Real World Solutions, IQVIA

Netherlands

United Kingdom (Northern Ireland)

Study timelines

Date when funding contract was signed

Planned: 01/05/2015

Actual: 01/05/2015

Study start date

Planned: 30/09/2015

Actual: 02/02/2016

Date of final study report

Planned: 10/11/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

gsk-201038-protocol-redact

Updated protocol

gsk-201038-protocol-amend4-redact

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)