drugset / Trial / NCT04609878

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

NCT04609878

Phase 3 Completed 2274 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start
2020-12-15
Primary completion
2025-03-21
Completion
2025-03-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Formoterol Other / unclassified 9 ug Inhaled
Subject Formoterol Other / unclassified 9.6 ug Inhaled
Subject Glycopyrronium Unknown 14.4 ug Inhaled
Subject Glycopyrronium Unknown 28.8 ug Inhaled
Background Budesonide Small molecule 320 ug Inhaled

Indications