BENITIONSClinical Trial Intelligence

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

3期 已完成 NCT03888131

适应症Chronic Obstructive Pulmonary Disease
分期3期
申办方Chiesi Farmaceutici S.p.A.
状态已完成
受试者人数750 人
干预(药物)CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo, Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo
开始日期2018年7月30日
完成日期2022年5月6日
结果公布日2026年5月12日

摘要

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.

Change From Baseline in Pre-dose Morning First Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Baseline and week 24 · liters

CHF 1535 100/6 µg pMDI - ITT Population-0.020 liters
Symbicort® Turbohaler® - ITT Population-0.019 liters
p-value<0.001
Adjusted Mean Difference-0.001 (95% CI -0.025–0.022)

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。