drugset / Trial / NCT05202262

A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS)

NCT05202262

Phase 3 Completed 645 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a 24 week study to evaluate the efficacy and safety of budesonide and formoterol fumarate metered dose inhaler in adults and adolescents with inadequately controlled asthma.

Timeline

Start
2022-01-12
Primary completion
2025-02-26
Completion
2025-02-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 160 ug Inhaled
Subject Budesonide Small molecule 320 ug Inhaled
Subject Formoterol Other / unclassified 9 ug Inhaled
Subject Formoterol Other / unclassified 9.6 ug Inhaled

Indications