drugset / Trial / NCT00489853

Evaluation of Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) Compared to Placebo and Oxis in Patients With Severe COPD

NCT00489853 ↗

Phase 4 Completed 137 enrolled AstraZeneca
RandomizedCrossoverQuadruple-blindTreatment

Summary

The purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease.

Timeline

Start
2007-07
Primary completion
2008-08
Completion
2008-08

Outcome

Met primary endpoint

paper Budesonide/formoterol prolonged EET 1 h post-morning dose versus formoterol by 69 s (P < 0.005) and placebo by 105 s (P < 0.0001) PMID 20692140 ↗

Drugs

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