drugset / Trial / NCT00652392

Efficacy of Symbicort pMDI Administered Once Daily in Adolescents and Adults During 12 Weeks - STEM

NCT00652392 ↗

Phase 3 Completed 750 enrolled AstraZeneca
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to compare a dose of Symbicort taken once daily with other dosage regimens of Symbicort , budesonide and placebo for the treatment of asthma in adolescents and adults

Timeline

Start
2003-04
Primary completion
—
Completion
2004-06

Outcome

Met primary endpoint

paper BUD/FM (once or twice daily) was more effective (p < or = 0.003) than BUD and PBO on evening peak expiratory flow (primary variable), PMID 20167145 ↗

Drugs

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

Indications