drugset / Trial / NCT04675463

The Effects of Inhaled Budesonide-formoterol-glycopyrronium in Moderate-to-severe COPD

NCT04675463

Unknown 50 enrolled ShiYue Li AstraZeneca · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The fixed-dose combination product Budesonide/Glycopyrronium/Formoterol Fumarate Inhalation Aerosol, BGF pMDI and dual combination product Glycopyrronium/Formoterol Fumarate Inhalation Aerosol , GFF pMDI are developed for maintenance treatment for patients with COPD. There are still some unmet medical needs and evidence gaps in COPD therapy, such as could BGF Inhalation Aerosphere reverse the disease progression such like airway-remodelling? Could BGF Inhalation Aerosphere reduce inflammation in small airways? Before differences proven between medication groups, pilot study is needed. This 52 weeks, Single-center, prospective, interventional pilot study could help discovering intervention effect of BGF and GFF on small airways through OCT measurement, which would show outcome of AEROSPHERE™ Delivery Technology on COPD patients.

Timeline

Start
2020-12-30
Primary completion
2023-01-30
Completion
2023-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 160 ug Inhaled
Background Formoterol Other / unclassified 4.8 ug Inhaled
Background Glycopyrronium Unknown 7.2 ug Inhaled