drugset / Trial / NCT00252785

Efficacy & Safety of Symbicort® TURBUHALER® 160/4.5 µg Twice Daily & Pulmicort® TURBUHALER® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Asthmatic Patients

NCT00252785

Phase 3 Completed 340 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this study is to confirm the efficacy (superiority) of Symbicort® Turbuhaler® 160/4.5 µg twice daily for 8 weeks in comparison to Pulmicort® Turbuhaler® 200 µg twice daily + Theolong® tablet 200 mg twice daily.

Timeline

Start
2005-10
Primary completion
Completion
2006-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 160 ug Inhaled
Subject Budesonide Small molecule 200 ug Inhaled
Subject Formoterol Other / unclassified 4.5 ug Inhaled
Subject Theophylline Small molecule 200 mg Oral

Indications