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

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ClinicalTrials.gov Identifier: NCT02096731
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : February 15, 2017
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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.


Condition or disease
Pulmonary Disease, Chronic Obstructive

Detailed Description:
Purpose:
Study Design
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Study Type : Observational
Actual Enrollment : 115397 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Combined Bronchodilators in Chronic Obstructive Pulmonary Disease and the Risk of Adverse Cardio-pulmonary Events: A Population-based Observational Study
Study Start Date : March 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Groups and Cohorts
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Group/Cohort
LABA + tiotropium
LABA mono
neither tiotropium nor LABA
tiotropium + LABA
tiotropium mono


Outcome Measures
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Primary Outcome Measures :
  1. Myocardial Infarction [ Time Frame: Up to 12 months ]

    The acute myocardial infarction (MI) rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.

    No. = Number


  2. Stroke [ Time Frame: Up to 12 months ]
    The stroke rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.

  3. Heart Failure [ Time Frame: Up to 12 months ]
    The heart failure (HF) rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.

  4. Cardiac Arrhythmia [ Time Frame: Up to 12 months ]
    The cardiac arrhythmia (CA) rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.

  5. Community Acquired Pneumonia [ Time Frame: Up to 12 months ]

    The community acquired pneumonia rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.

    Pt. = Patient



Eligibility Criteria
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Ages Eligible for Study:   55 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Users of tiotropium or long-acting beta agonists
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096731


Locations
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Canada, Quebec
Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02096731    
Other Study ID Numbers: 205.526
First Posted: March 26, 2014    Key Record Dates
Results First Posted: February 15, 2017
Last Update Posted: February 15, 2017
Last Verified: December 2016
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases