A study evaluating the efficacy of budesonide, glycopyrronium and formoterol fumarate metered dosed inhaler on cardiopulmonary outcomes in chronic obstructive pulmonary disease (THARROS)
A study evaluating the efficacy of budesonide, glycopyrronium and formoterol fumarate metered dosed inhaler on cardiopulmonary outcomes in chronic obstructive pulmonary disease (THARROS)
ClinicalTrials.gov ID: NCT06283966
Sponsor: AstraZeneca
Information provided by: AstraZeneca (Responsible Party)
Last Update Posted: 2024-03-12
Brief 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.
Official Title:
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)
Intervention / Treatment:
- Drug: BGF MDI 320/14.4/9.6 μg
- Drug: GFF MDI 14.4/9.6 μg
| Category | Value |
|---|---|
| Study Start (Actual) |
2024-02-21
|
| Primary Completion (Estimated) |
2028-03-06
|
| Study Completion (Estimated) |
2028-03-06
|
| Enrollment (Estimated) | 5000 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
D5989C00001
|