Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD) (TRIVERSYTI)

3期已完成 NCT03197818

适应症	COPD
分期	3期
申办方	Chiesi Farmaceutici S.p.A.
状态	已完成
受试者人数	708 人
干预（药物）	CHF 5993 100/6/12.5 µg, 160 µg budesonide + 4.5 µg formoterol fumarate
开始日期	2016年12月14日
完成日期	2020年5月26日
结果公布日	2026年5月27日

摘要

Primary Objective • To demonstrate the superiority of CHF 5993 pressurised metered dose inhaler (pMDI) over Symbicort® Turbuhaler® in terms of pulmonary function (change from baseline in pre-dose morning forced expiratory volume in the first second of a forced vital capacity manoeuvre \[FEV1\] and 2-hour post-dose morning FEV1 at Week 24). Secondary Objectives Key secondary objective: • To demonstrate the superiority of CHF 5993 pMDI over Symbicort® Turbuhaler® in terms of pulmonary function (change from baseline in pre-dose morning FEV1 and 2-hour post-dose morning FEV1 at Week 24) in the subgroup of Chinese population. Other secondary objectives: * To evaluate the effect of CHF 5993 pMDI on other lung function parameters, patient's health status and clinical outcome measures; * To collect data in order to assess the impact of study treatments on health economic outcomes; * To assess the safety and the tolerability of the study treatments.

Change From Baseline in Pre-dose Forced Expiratory Volume Within the First Second (FEV1) at Week 24

Week 24 (Visit 6) · Liters

CHF 5993 100/6/12.5 µg - ITT Population	0.030 Liters
Symbicort Turbuhaler 160/4.5 µg - ITT Population	-0.032 Liters

p-value	< 0.001
adjusted mean difference	0.062 (95% CI 0.038–0.085)

Change From Baseline in 2-hour Post-dose FEV1 at Week 24

Week 24 (Visit 6) · Liters

CHF 5993 100/6/12.5 µg - ITT Population	0.185 Liters
Symbicort Turbuhaler 160/4.5 µg - ITT Population	0.072 Liters

p-value	< 0.001
adjusted mean difference	0.113 (95% CI 0.087–0.140)

在 BENITIONS 中查看查看 ClinicalTrials.gov 原文

同一适应症的其他试验

Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and — University of Tennessee Graduate School of Medicine
Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster — Chiesi Farmaceutici S.p.A.
Tiotropium/Salmeterol Inhalation Powder in COPD — Boehringer Ingelheim
Risk Factors, Costs, and Impacts of ED Boarding — University of Maryland, Baltimore
Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructiv — United Therapeutics
Anti-Platelets in Chronic Obstructive Pulmonary Disease — Brigham and Women's Hospital

全部试验

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。

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