drugset / Trial / NCT00646321

Efficacy of Symbicort pMDI Administered Once Daily in Children and Adolescents During 12 Weeks - SPROUT

NCT00646321 ↗

Phase 3 Completed 540 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to compare Symbicort with budesonide alone for the treatment of asthma in children aged 6 to 15 years

Timeline

Start
2003-04
Primary completion
—
Completion
2004-08

Outcome

Met primary endpoint

paper Once- or twice-daily budesonide/formoterol was more effective than budesonide for evening peak expiratory flow (primary variable) at the end of the 24-hour once-daily dosing interval (P<or=.027). PMID 20713475 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 40 ug Inhaled
Subject Budesonide Small molecule 80 ug Inhaled
Subject Formoterol Other / unclassified 4.5 ug Inhaled

Indications