BENITIONSClinical Trial Intelligence

TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA

3期 已完成 NCT02676076

适应症Asthma
分期3期
申办方Chiesi Farmaceutici S.p.A.
状态已完成
受试者人数1,155 人
干预(药物)CHF 5993 100/6/12.5, CHF 1535 100/6 µg
开始日期2016年2月17日
完成日期2018年5月17日
结果公布日2026年6月26日

摘要

Evaluate the superiority of CHF 5993 100/6/12.5 µg Pressurised Metered Dose Inhaler (pMDI) (fixed combination of extrafine beclometasone dipropionate (BDP) plus formoterol fumarate (FF) plus glycopyrronium bromide \[GB\]) versus CHF 1535 100/6 µg pMDI (fixed combination of extrafine beclometasone dipropionate (BDP) plus formoterol fumarate \[FF\]), with regard to lung functions parameters and rate of exacerbations as well as safety and health economics outcomes, in adult patients with uncontrolled asthma on medium doses of inhaled corticosteroids in combination with long acting ß2 agonists (LABA).

1_Change From Baseline in Pre-Dose Forced Expiratory Volume in the First Second (FEV1) at Week 26

Week 0 (pre-treatment, baseline) to Week 26. · Liter

CHF 5993 100/6/12.5 µg0.185 Liter
CHF 1535 100/6 µg0.127 Liter
p-value0.008
Adjusted mean difference0.057 (95% CI 0.015–0.099)

2_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period

Week 0 (pre-treatment, baseline) to Week 52. · events/year

CHF 5993 100/6/12.5 µg1.825 events/year
CHF 1535 100/6 µg2.157 events/year
p-value0.033
Adjusted rate ratio0.846 (95% CI 0.725–0.987)

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

同一适应症的其他试验

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。