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

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Study type: Observational

Funder types: Industry

Identifiers

NCT03405363

1222.54

Details and patient eligibility

About

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.

Full description

Purpose:

Time Perspective:

Enrollment: 65,406 patients

Sex: All

Ages: 40 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

65,406 participants in 2 patient groups

new users of Olodaterol

Description:

COPD patients using Olodaterol for the first time

new users of other LABAs

Description:

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