A Randomised, Double-blind, Multi-centre, Placebo-controlled, Crossover Study to Assess the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler on Cardiac and Lung Function in Participants with Chronic Obstructive Pulmonary Disease and Hyperinflation (ORATOS)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521987-37-00

Acronym

D5980C00048

Enrollment

Registered

2025-09-15

Start date

2025-11-06

Completion date

Unknown

Last updated

2026-01-14

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

Conditions

Chronic Obstructive Pulmonary Disease

Brief summary

Change from baseline in left ventricular end diastolic volume (LVEDVi) measured by magnetic resonance imaging (MRI).

Detailed description

Change from baseline in functional residual capacity/total lung capacity (FRC/TLC) measured by body plethysmography., Change from baseline in residual volume/total lung capacity (RV/TLC) measured by body plethysmography

Interventions

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

DRUGsuspension

DRUGThe placebo MDI is formulated as a suspension of spray-dried porous particles (consisting of 1

DRUG2-distearoyl-sn-glycero-3-phosphocholine [DSPC] and calcium chloride) in a hydrofluoroalkane propellant (HFA-134a). The placebo MDI uses the same excipients as active product but with absence of the active pharmaceutical ingredient (API).

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in left ventricular end diastolic volume (LVEDVi) measured by magnetic resonance imaging (MRI).	—

Secondary

Measure	Time frame
Change from baseline in functional residual capacity/total lung capacity (FRC/TLC) measured by body plethysmography., Change from baseline in residual volume/total lung capacity (RV/TLC) measured by body plethysmography	—

Countries

Germany

Outcome results

None listed

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