Combined Bronchodilators in Chronic Obstructive Pulmonary Disease and the Risk of Adverse Cardio-pulmonary Events

NCT ID: NCT02096731

Last Updated: 2017-02-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 115397 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-08-31

Brief Summary

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.

Detailed Description

Purpose:

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

LABA + tiotropium

No interventions assigned to this group

LABA mono

No interventions assigned to this group

neither tiotropium nor LABA

No interventions assigned to this group

tiotropium + LABA

No interventions assigned to this group

tiotropium mono

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• New users of long-acting bronchodilators, either a LABA or tiotropium, between January 2002 and August 2012
• Age >= 55 years

Exclusion Criteria

• Use of LABA or tiotropium in the two years prior to cohort entry

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

205.526

Identifier Type: -

Identifier Source: org_study_id