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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)

Objective

Status Enrolling

Condition Chronic Obstructive Pulmonary Disease (COPD)

Description

Observational Study on COPD starting new medication

Purpose

1) Demonstrate non inferiority of UMEC/VI combination and UMEC to tiotropium for risk of Myocardial Infarction, stroke or heart failure individually based on an analysis of time to first event.

2) To quantify the incidence rate and frequency of MI, stroke, and heart failure for new users of UMEC/VI combination, UMEC, and tiotropium.

Phase IV

Key Inclusion Criteria

  1. Diagnosis of COPD verified by spirometry
  2. Adults over age 18 years who provide written informed consent
  3. Patient Medical Records available for at least 12 months prior to enrollment

Key Exclusion Criteria

  1. Current participation in any interventional clinical trials in which treatment regimen and/or monitoring is dictated by protocol
  2. Patients with hypersensitivity to UMEC, VI, tiotropium or excipients
  3. Maintenance treatment with a LAMA-containing medication during the 12 months prior to enrollment. Maintenance treatment is defined as 60 or more days of continuous use.

ClinicalTrials.gov Identifier

NA

Protocol Number

201038

Principal Investigator(s)
Wayne Breitwieser, MD

Clinical Trial Categories

  • Pulmonology
Sponsor(s)
GlaxoSmithKline
Contact
Renee Hendrickson, RN CCRC at 701-780-1694
or rhendrickson@altru.org