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

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507407-59-00

Acronym

D5989C00001 THARROS

Enrollment

1365

Registered

2024-06-10

Start date

2024-07-04

Completion date

Unknown

Last updated

2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Brief summary

Time to first severe cardiac or COPD event.

Detailed description

-Time to first severe COPD exacerbation -Time to first severe cardiac event -Time to cardiopulmonary death -moderate/severe COPD exacerbation rate -Time to MI hospitalization (or cardiac death) -Time to HF acute healthcare visit/hospitalization (or cardiac death)

Interventions

DRUGTrixeo Aerosphere 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation

DRUGsuspension

DRUGBevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation

DRUGSALBUTAMOL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to first severe cardiac or COPD event.	—

Secondary

Measure	Time frame
-Time to first severe COPD exacerbation -Time to first severe cardiac event -Time to cardiopulmonary death -moderate/severe COPD exacerbation rate -Time to MI hospitalization (or cardiac death) -Time to HF acute healthcare visit/hospitalization (or cardiac death)	—

Countries

Austria, Bulgaria, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Norway, Poland, Romania, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026