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

NCT ID: NCT03405363

Last Updated: 2021-04-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65406 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-31

Study Completion Date

2020-02-03

Brief Summary

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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 other LABAs available for the treatment of COPD.

Detailed Description

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Purpose:

Time Perspective:

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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new users of Olodaterol

COPD patients using Olodaterol for the first time

No interventions assigned to this group

new users of other LABAs

COPD patients using other long-acting beta2 agonists for the first time

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Aarhus Universitets hospital Skejby

Aarhus, , Denmark

Site Status

Countries

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Denmark

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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1222.54

Identifier Type: -

Identifier Source: org_study_id

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