drugset / Trial / NCT05755906

A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants With Inadequately Controlled Asthma (LITHOS)

NCT05755906

Phase 3 Completed 374 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a 12-week study to evaluate the efficacy and safety of budesonide and formoterol fumarate metered dose inhaler relative to budesonide metered dose inhaler in adults and adolescents with inadequately controlled asthma.

Timeline

Start
2023-02-27
Primary completion
2024-11-19
Completion
2024-11-19

Drugs

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

Indications