NCT04671355

TRIMBOW® and RELVAR® on Lung Stiffness Reduction Assessed Through Forced Oscillation Technique in Patients With COPD

A Phase IV, Open Label, Multicentre, Randomised, 2-way Cross-over Exploratory Clinical Trial Comparing TRIMBOW® pMDI and RELVAR® ELLIPTA® DPI on Lung Stiffness Reduction Assessed Through Area Under the Reactance Curve (AX) in COPD.

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Efficacy of TRIMBOW® pMDI and RELVAR® ELLIPTA® DPI on lung stiffness reduction assessed through area under the reactance curve (AX) using oscillometry in chronic obstructive pulmonary disease (COPD).

Detailed description

An open label, multicentre, randomised, 2-way cross-over exploratory clinical trial comparing a fixed combination of beclometasone dipropionate plus formoterol fumarate plus glycopyrronium administered via pMDI (TRIMBOW®) and a fixed combination of fluticasone furoate plus vilanterol administered via DPI (RELVAR® ELLIPTA®) on lung stiffness reduction assessed through area under the reactance curve (AX) using forced oscillation technique (FOT) in patients with chronic obstructive pulmonary disease (COPD).

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	Beclometasone Dipropionate / Formoterol Fumarate / Glycopyrronium 100/6/10 mcg	Pressurized metered dose inhaler
DRUG	Fluticasone Furoate / Vilanterol Trifenatate 100/25 mcg	Dry powder inhaler

Timeline

• Start date: 2021-10-04
• Primary completion: 2021-12-22
• Completion: 2022-02-18
• First posted: 2020-12-17
• Last updated: 2022-02-03