Combined bronchodilators in COPD and the risk of adverse cardio-pulmonary events: A population-based observational study (Comb Bronchodil in COPD and CardPulm AEs)

Study identification

• EU PAS number:
  EUPAS6134
• Study ID:
  19335
• Official title and acronym:
  Combined bronchodilators in COPD and the risk of adverse cardio-pulmonary events: A population-based observational study (Comb Bronchodil in COPD and CardPulm AEs)
• DARWIN EU® study:
  No
• Study countries:
  Canada
• Study description:
  Background: Recent observational studies have reported possible arrhythmogenic effects with long-acting beta-agonists (LABA), while the long-acting anticholinergic tiotropium has been associated with cardiovascular and cerebrovascular events. Finally, pneumonia was the object of a recent signal in trials of LABAs submitted for marketing approval. Aim: To assess the potential cardio-pulmonary risk arising from the concurrent use of two long-acting bronchodilators as well as from monotherapy use of each of the long-acting bronchodilators. Methods: A series of population-based cohort studies, using both cohort and nested case-control analyses will be conducted using data from the United Kingdom's Clinical Practice Research Datalink (CPRD). The base cohort will consist of new users of long-acting bronchodilators from Jan 2002 until Aug 2012, age >= 55 with chronic obstructive pulmonary disease (COPD) and at least two years of baseline medical history information. The high-dimensional propensity score technique will be used to match new users of each long-acting bronchodilator and new users of two bronchodilators with comparable subjects from the base cohort, with one-year follow-up for outcomes of acute myocardial infarction, stroke, heart failure, arrhythmia and community acquired pneumonia. Data will be analysed using time-dependent Cox proportional hazard regression models and conditional logistic regression models.
• Study status:
  Finalised

Research institutions and networks

Institutions

McGill University

Study timelines

Date when funding contract was signed

Planned: 10/05/2013

Actual: 10/05/2013

Study start date

Planned: 01/11/2013

Actual: 24/03/2014

Data analysis start date

Planned: 01/02/2014

Actual: 25/03/2014

Date of interim report, if expected

Planned: 30/09/2014

Date of final study report

Planned: 31/05/2016

Actual: 31/05/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim GmbH

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable