drugset / Trial / NCT00479739

CONCEPT: A 1-Year Comparison Of A Stable Dose Of SERETIDE® Inhaler With An Adjustable Maintenance Dose Of SYMBICORT® Inhaler. SERETIDE® Inhaler is a Trademark of GSK Group of Companies. SYMBICORT® Inhaler is a Trademark of Astra Zeneca.

NCT00479739 ↗

Phase 4 Completed 700 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

Summary

To compare a stable dose of salmeterol/fluticasone propionate with a variable dose of formoterol/budesonide where the dose is adjusted according to a physician-guided self-management plan

Timeline

Start
2002-11
Primary completion
2004-07
Completion
2004-07

Outcome

Met primary endpoint

paper The percentage of symptom-free days was significantly greater (58.8% vs 52.1%; p = 0.034) PMID 17610727 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 200 ug Inhaled
Subject Fluticasone propionate Other / unclassified 250 ug Inhaled
Subject Formoterol Other / unclassified 6 ug Inhaled
Subject Salmeterol Other / unclassified 50 ug Inhaled

Indications