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Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis

NCT00737100 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2014-05-16

Study results available
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Summary

This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations

Conditions

Interventions

DRUG

Placebo Respimat

patient to receive placebo matching active drug once daily

DRUG

Tiotropium bromide 5 mcg

patient to recieve high dose tiotropium once daily

DRUG

tiotropium bromide-low dose-2.5mcg

patient to receive low dose tiotropium once daily

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-04-30

Countries

  • United States
  • Australia
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • New Zealand
  • Portugal
  • Russia
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT00737100 on ClinicalTrials.gov