Trial Profile

A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter Variable Length Study to Assess the Efficacy and Safety of PT010 Relative to PT009 and Symbicort in Adult and Adolescent Participants With Inadequately Controlled Asthma

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 24 Dec 2025

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At a glance

Drugs Budesonide/formoterol/glycopyrrolate (Primary) ; Budesonide/formoterol
Indications Asthma
Focus Registrational; Therapeutic Use
Acronyms KALOS
Sponsors AstraZeneca; AstraZeneca AB

06 Nov 2025 According to AstraZeneca media release, based on results form this trial and LOGOS trial the company has filed BLA for Breztri for treatment of Uncontrolled asthma in US, EU, JP, CN.
02 May 2025 Primary endpoint (Rate of severe asthma exacerbations) has been met.
02 May 2025 Primary endpoint (Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24) has been met.

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