drugset / Trial / NCT01772368

Dose Ranging Study of the Salmeterol Component of Fluticasone /Salmeterol Spiromax Compared to Fluticasone Spiromax and Advair Diskus in Asthma Subjects

NCT01772368

Phase 2 Completed 72 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedCrossoverDouble-blindTreatment

Summary

The primary objective of this study is to evaluate the dose response, efficacy, and safety of 4 different doses of salmeterol Spiromax (6.25, 12.5, 25, and 50 mcg) each combined with a fixed dose of fluticasone propionate (100 mcg) delivered as Fluticasone/Salmeterol Spiromax® Inhalation Powder (FS Spiromax) when administered as a single dose in subjects 12 years of age and older with persistent asthma.

Timeline

Start
2013-01
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone propionate Other / unclassified 100 ug Inhaled
Subject salmeterol xinafoate Unknown 6.25 ug Inhaled
Subject salmeterol xinafoate Unknown 12.5 ug Inhaled
Subject salmeterol xinafoate Unknown 25 ug Inhaled
Subject salmeterol xinafoate Unknown 50 ug Inhaled
Background Salbutamol Unknown Inhaled

Indications