drugset / Trial / NCT01785433

To Compare the Pharmacokinetics of Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT01785433

Phase 1/2 Completed 36 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedCrossoverOpen-labelTreatment

Summary

The primary objective of this study is to assess and compare the pharmacokinetics (PK) of Tiotropium delivered via Breath Actuated Inhaler (BAI) (4.5 mcg/day or 9.0 mcg/day), SPIRIVA®, HandiHaler®, (18 mcg/day) and Respimat® Soft Mist™ Inhaler (SMI) (5.0 mcg/day) following repeat dosing for 7 days in subjects with COPD.

Timeline

Start
2013-01
Primary completion
2013-07
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Tiotropium Other / unclassified 4.5 ug Inhaled
Subject Tiotropium Other / unclassified 5 ug Inhaled
Subject Tiotropium Other / unclassified 9 ug Inhaled
Subject Tiotropium Other / unclassified 18 ug Inhaled