NCT06283966

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

A Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,000 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase III randomized, double-blind, parallel group, multi-center event-driven study comparing BGF MDI 320/14.4/9.6 μg BID with GFF MDI 14.4/9.6 μg BID in participants with COPD who are at risk of a cardiopulmonary event.

Conditions

• COPD (Chronic Obstructive Pulmonary Disease)

Interventions

Type	Name	Description
DRUG	BGF MDI 320/14.4/9.6 μg	Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension
DRUG	GFF MDI 14.4/9.6 μg	Glycopyrronium and formoterol fumarate pressurized inhalation suspension

Timeline

• Start date: 2024-02-21
• Primary completion: 2028-03-07
• Completion: 2028-03-07
• First posted: 2024-02-28
• Last updated: 2026-03-04

Locations

917 sites across 37 countries: United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Malaysia, Mexico, Norway, Peru, Philippines, Poland, Romania, Serbia, Slovakia, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study