drugset / Trial / NCT00463866

Local Phase 4 Pan-European SMART Study

NCT00463866 ↗

Phase 4 Completed 8424 enrolled AstraZeneca
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period

Timeline

Start
2007-03
Primary completion
—
Completion
2008-12

Outcome

Met primary endpoint

paper In the total study population, the time to first severe asthma exacerbation was prolonged by 18% with 2 × 2 versus 1 × 2 (hazard ratio 0.82; p = 0.03). PMID 20595145 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject budesonide/formoterol Unknown 4.5 ug Inhaled
Subject budesonide/formoterol Unknown 160 ug Inhaled

Indications