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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Combined Bronchodilators in Chronic Obstructive Pulmonary Disease and the Risk of Adverse Cardio-pulmonary Events: A Population-based Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096731
• Other study ID #: 205.526
• Status: Completed
• Phase: N/A
• First received: March 24, 2014
• Last updated: January 26, 2016
• Start date: March 2014
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

Description:

Purpose:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 100 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Canada	205.526.1 Boehringer Ingelheim Investigational Site	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	myocardial infarction		up to 12 months	Yes
Primary	Heart failure		up to 12 months	Yes
Primary	Stroke		up to 12 months	No
Primary	Cardiac arrhythmia		up to 12 months	Yes
Primary	Community acquired pneumonia		up to 12 months	No