NCT03333018 - A Drug Utilisation Post-authorisation Study of New Users of Aclidinium Bromide (Monotherapy or in Combination) | Biotech Hunter

Enrollment

22,155

Participants

Timeline

Start Date

July 6, 2015

Primary Completion Date

February 28, 2017

Study Completion Date

February 28, 2017

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Aclidinium bromide

Administered as monotherapy, prescribed as recorded in the database.

DRUG

Aclidinium bromide/formoterol

Administered in combination with formoterol fumarate (concomitant or as a fixed-dose combination), prescribed as recorded in the database.

DRUG

Other COPD medication

"Other COPD medication including:~tiotropium; other long-acting anticholinergic (LAMAs; lycopyrronium bromide, umeclidinium); LABA (formoterol, salmeterol, indacaterol); LABA/ICS (formoterol/budesonide, formoterol/beclometasone, formoterol/mometasone, formoterol/fluticasone, salmeterol/fluticasone propionate, and vilanterol/fluticasone); LAMA/LABA (approved or under regulatory review or in development; glycopyrrolate/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, umeclidinium/vilanterol), prescribed as recorded in the database."

Trial Locations (3)

Unknown

National Health Database Denmark, Southern Denmark University, Odense

German Pharmacoepidemiological Research Database, Bremen

Clinical Practice Research Datalink, London