drugset / Trial / NCT00259779

Comparison Between Symbicort® and Prednisolone in COPD

NCT00259779 ↗

Phase 3 Completed 120 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

Summary

To assess if Symbicort forte Turbuhaler (during two weeks) is as effective as an oral course of prednisolone + Oxis Turbuhaler (during two weeks) for the treatment of an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD).

Timeline

Start
2005-09
Primary completion
—
Completion
2007-07

Outcome

Met primary endpoint

paper Non-inferiority of budesonide/formoterol was proven because the lower limit of FEV1-change (97.5% CI) was above 90% of the efficacy of the alternative treatment. PMID 19228428 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 320 ug Inhaled
Subject Formoterol Other / unclassified 9 ug Inhaled
Subject Prednisolone Other / unclassified 30 mg Oral