drugset / Trial / NCT01484197

A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device

NCT01484197

Phase 2 Completed 36 enrolled Novartis Pharmaceuticals
RandomizedCrossoverTriple-blindTreatment

Summary

This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two different formulations of indacaterol maleate, both administered via the Concept1 device. The study aims to determine whether the novel formulation has a similar clinical profile as the established formulation.

Timeline

Start
2011-11
Primary completion
2012-05
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Indacaterol Other / unclassified 37.5 ug Inhaled
Subject Indacaterol Other / unclassified 75 ug Inhaled

Indications