Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient (FORSYYN)

Summary

Primary Objective To demonstrate that CHF 1535 pMDI is non-inferior to Symbicort® Turbohaler® in terms of pulmonary function (change from baseline in pre-dose morning FEV1 at Week 24) in patients with COPD. Secondary Objectives * To evaluate the effect of CHF 1535 pMDI on other lung function parameters, and patient reported outcomes (PROs); * To assess the safety and the tolerability of the study treatments.

Timeline

Start

2018-07-30

Primary completion

2022-05-06

Completion

2022-05-06

Outcome

Met primary endpoint

paper The primary endpoint was met in both the per-protocol PMID 39529298 ↗

registry analysis (non-inferiority test); CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population; p <0.001; Adjusted Mean Difference -0.001 (95% CI -0.025 to 0.022) NCT03888131 ↗

Publications

• Results Wen F, Wu Y, Xing C, Zhu Y, Chen Y, Mei X, Corradi M, Cappellini G, Calabro E, Amodio S, Zhu C, Galkin D. Beclometasone Dipropionate/Formoterol Fumarate is Similarly Effective to Budesonide/Formoterol Fumarate in Chinese Patients with COPD: The FORSYYN Double-Blind, Randomised Study. COPD. 2024 Dec;21(1):2425157. doi: 10.1080/15412555.2024.2425157. Epub 2024 Nov 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Budesonide	Small molecule	160 ug	Inhaled
Subject	Formoterol	Other / unclassified	4.5 ug	Inhaled
Subject	Formoterol	Other / unclassified	6 ug	Inhaled
Subject	beclomethasone dipropionate	Other / unclassified	100 ug	Inhaled

Indications