BENITIONSClinical Trial Intelligence

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

第3相 完了 NCT02676076

対象疾患Asthma
第3相
スポンサーChiesi Farmaceutici S.p.A.
ステータス完了
参加者数1,155 名
介入(薬剤)CHF 5993 100/6/12.5, CHF 1535 100/6 µg
開始日2016年2月17日
完了日2018年5月17日
結果公開日2026年6月26日

概要

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)

BENITIONS で見る ClinicalTrials.gov の原文を見る

同じ疾患の他の治験

すべての治験

このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。