drugset / Trial / NCT00989833

Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients

NCT00989833

Phase 2 Completed 66 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

Summary

1. The primary objective of this study is: * To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol on an as-needed basis compared to the use of terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma 2. The secondary objectives of this study are: * To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol as-needed compared to regular once daily use of budesonide plus terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma * To evaluate safety of budesonide/formoterol as-needed, terbutaline as-needed and regular use of budesonide + terbutaline as-needed as terms of adverse event

Timeline

Start
2009-09
Primary completion
2010-07
Completion
2010-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Budesonide Small molecule 160 ug Inhaled
Comparator Budesonide Small molecule 400 ug Inhaled
Comparator Formoterol Other / unclassified 4.5 ug
Comparator Terbutaline Small molecule 0.4 mg Inhaled