NCT01785433

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

A Randomized, Open-Label, Repeat Dosing, Four-Period Crossover Study to Compare the Pharmacokinetics, Efficacy and Safety of Tiotropium Bromide Delivered Via Breath Actuated Inhaler (BAI), SPIRIVA® HandiHaler® and Respimat® Soft Mist™ Inhaler (SMI) in Subjects With COPD

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This multicenter study consists of a Screening Visit (3 to 14 days prior to randomization); 4 multiple-dose (7-day) Treatment Periods, each consisting of a 2-night/3-day inpatient stay (Day 6 to Day 8); and a Final Visit. A washout period of at least 21 days will occur between each Treatment Period. The Final/ Early Termination Visit will occur 6-8 days following the last Treatment Period or upon early discharge from the study.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	Tiotropium HFA BAI 4.5 mcg
DRUG	Tiotropium HFA BAI 9.0 mcg
DRUG	SPIRIVA® HandiHaler® 18 mcg/day
DRUG	Spiriva® Respimat® 5 mcg/day

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-07-01
• Completion: 2013-08-01
• First posted: 2013-02-07
• Last updated: 2014-08-11

Locations

5 sites across 1 country: Germany