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Tiotropium Respimat Pharmacokinetic Study in COPD

NCT01222533 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2014-05-16

Study results available
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Summary

The purpose of this study is compare the effect of different doses of tiotropium delivered by the HandiHaler and Respimat device on lung function. Additionally, the study will investigate the pharmacokinetic profile of these different doses. Studying the pharmacokinetic profile shows what happens to the medication in the body over a period of hours and provides information on potential effects of the medication.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Tiotropium medium

Tiotropium inhalation solution medium dose

DRUG

Tiotropium low

Tiotropium inhalation solution low dose

DRUG

Tiotropium high

Tiotropium inhalation solution high dose

DRUG

Tiotropium 18mcg

Tiotropium inhalation powder 18mcg

DRUG

Tiotropium placebo

Placebo inhalation solution

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-11-30

Countries

  • Belgium
  • Denmark
  • Finland
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01222533 on ClinicalTrials.gov