Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)

3期已完成 NCT04609878

适应症	Asthma
分期	3期
申办方	AstraZeneca
状态	已完成
受试者人数	2,274 人
干预（药物）	BGF MDI 320/28.8/9.6 μg, BGF MDI 320/14.4/9.6 μg, BFF MDI 320/9.6 μg, BFF pMDI 320/9 μg
开始日期	2020年12月15日
完成日期	2025年3月21日
结果公布日	2026年6月30日

摘要

This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care

Change From Baseline in FEV1 AUC0-3 (L) at Week 24

Week 24 · Liters

BGF MDI 320/14.4/9.6 μg BID	0.281 ± 0.018 Liters
BGF MDI 320/28.8/9.6 μg BID	0.316 ± 0.014 Liters
BFF MDI 320/9.6 μg BID	0.249 ± 0.014 Liters
Symbicort® pMDI 320/9 μg BID	0.220 ± 0.014 Liters

p-value	0.168
LS Mean Difference	0.032 (95% CI -0.013–0.077)

Pooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations

Up to 52 weeks · Exacerbations/Subject Years

BGF MDI 320/14.4/9.6 μg BID	0.533 Exacerbations/Subject Years
BGF MDI 320/28.8/9.6 μg BID	0.541 Exacerbations/Subject Years
BFF MDI 320/9.6 μg BID	0.604 Exacerbations/Subject Years
Symbicort® pMDI 320/9 μg BID	0.662 Exacerbations/Subject Years

p-value	0.120
Rate ratio	0.882 (95% CI 0.754–1.033)

在 BENITIONS 中查看查看 ClinicalTrials.gov 原文

同一适应症的其他试验

A Study of Remote Asthma Management Using an Integrated Artificial Intelligence-assisted E — Mayo Clinic
Developing a Childhood Asthma Risk Passive Digital Marker — Indiana University
A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With C — Chiesi Farmaceutici S.p.A.
A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to — Hoffmann-La Roche
A Study of Lebrikizumab in Participants With Uncontrolled Asthma Who Are on Inhaled Cortic — Hoffmann-La Roche
Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Sev — AstraZeneca

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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