Status:

COMPLETED

Cardiovascular Events in Chronic Obstructive Pulmonary Disease Patients Initiating Olodaterol or Other Long-acting beta2 Agonists

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Pulmonary Disease, Chronic Obstructive

Eligibility:

All Genders

40-100 years

Brief Summary

Examine the risk of cardiovascular events (cardiac arrhythmia or myocardial ischemia) or all-cause mortality in Chronic Obstructive Pulmonary Disease (COPD) patients who are new users of Olodaterol or...

Detailed Description

Purpose: Time Perspective:

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • COPD diagnosis
  • aged 40 years or older (to minimise the likelihood of including individuals who have asthma only)
  • New user of olodaterol or a new user of indacaterol, salmeterol, or formoterol (not in fixed-dose combination with an inhaled corticosteroid) and have no dispensing of any LABA in the 6 months before the index date
  • at least 1 year of enrolment in the electronic database before their first LABA dispensing (defined as the index LABA)
  • Complete data on sex
  • Exclusion criteria:
  • none

Exclusion

    Key Trial Info

    Start Date :

    January 31 2018

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    February 3 2020

    Estimated Enrollment :

    65406 Patients enrolled

    Trial Details

    Trial ID

    NCT03405363

    Start Date

    January 31 2018

    End Date

    February 3 2020

    Last Update

    April 30 2021

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Aarhus Universitets hospital Skejby

    Aarhus, Denmark