drugset / Trial / NCT06283966

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

NCT06283966

Phase 3 Recruiting 5250 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.

Timeline

Start
2024-02-21
Primary completion
2027-12-03
Completion
2027-12-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 320 ug Inhaled
Background Formoterol Other / unclassified 9.6 ug Inhaled
Background Glycopyrronium Unknown 14.4 ug Inhaled