Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints

CompletedOBSERVATIONAL
Enrollment

26,839

Participants

Timeline

Start Date

March 1, 2017

Primary Completion Date

June 30, 2022

Study Completion Date

June 30, 2022

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

Aclidinium bromide

Administered as monotherapy, concomitant with formoterol not in fixed-dose combination, or fixed-dose aclidinium/formoterol

DRUG

Other COPD medication

"Users of the following COPD medications:~Tiotropium~Other long-acting anticholinergic (LAMAs): glycopyrronium bromide, umeclidinium~LABA: formoterol, salmeterol, indacaterol~LABA/ICS (LABA in fixed-dose combinations with ICS): formoterol/budesonide, formoterol/beclometasone, formoterol/mometasone, formoterol/fluticasone, salmeterol/fluticasone, and vilanterol/fluticasone.~LAMA/LABA (approved or under regulatory review or in development): glycopyrrolate/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, umeclidinium/vilanterol"

Trial Locations (1)

Unknown

Clinical Practice Research Datalink, London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

RTI Health Solutions

OTHER

lead

AstraZeneca

INDUSTRY