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

May 7, 2014 updated by: Boehringer Ingelheim

A Randomized, Double-blind, Placebo-controlled Parallel Group Study to Investigate the Safety and Efficacy of Two Doses of Tiotropium Bromide (2.5 mcg and 5 mcg) Administered Once Daily Via the Respimat Device for 12 Weeks in Patients With Cystic Fibrosis.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

510

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia
        • 205.339.100 Boehringer Ingelheim Investigational Site
      • Westmead, New South Wales, Australia
        • 205.339.101 Boehringer Ingelheim Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia
        • 205.339.103 Boehringer Ingelheim Investigational Site
    • Western Australia
      • Subiaco, Western Australia, Australia
        • 205.339.104 Boehringer Ingelheim Investigational Site
  • Belgium
      • Bruxelles, Belgium
        • 205.339.111 Boehringer Ingelheim Investigational Site
      • Jette, Belgium
        • 205.339.112 Boehringer Ingelheim Investigational Site
      • Leuven, Belgium
        • 205.339.110 Boehringer Ingelheim Investigational Site
  • France
      • Amiens, France
        • 205.339.3310A Boehringer Ingelheim Investigational Site
      • Angers, France
        • 205.339.3317A Boehringer Ingelheim Investigational Site
      • Angers, France
        • 205.339.3317C Boehringer Ingelheim Investigational Site
      • Angers, France
        • 205.339.3317D Boehringer Ingelheim Investigational Site
      • Angers, France
        • 205.339.3317E Boehringer Ingelheim Investigational Site
      • BRON Cedex, France
        • 205.339.3314A Boehringer Ingelheim Investigational Site
      • BRON Cedex, France
        • 205.339.3314B Boehringer Ingelheim Investigational Site
      • BRON Cedex, France
        • 205.339.3314C Boehringer Ingelheim Investigational Site
      • Lille, France
        • 205.339.3302B Boehringer Ingelheim Investigational Site
      • Lille Cedex, France
        • 205.339.3302A Boehringer Ingelheim Investigational Site
      • Lille Cedex, France
        • 205.339.3302C Boehringer Ingelheim Investigational Site
      • Lisieux, France
        • 205.339.3303A Boehringer Ingelheim Investigational Site
      • Montpellier, France
        • 205.339.3304A Boehringer Ingelheim Investigational Site
      • Montpellier, France
        • 205.339.3304B Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 205.339.3308A Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 205.339.3308B Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 205.339.3308C Boehringer Ingelheim Investigational Site
      • Paris, France
        • 205.339.3312A Boehringer Ingelheim Investigational Site
      • Paris, France
        • 205.339.3312C Boehringer Ingelheim Investigational Site
      • Paris, France
        • 205.339.3313A Boehringer Ingelheim Investigational Site
      • Paris, France
        • 205.339.3313B Boehringer Ingelheim Investigational Site
      • Paris Cedex 14, France
        • 205.339.3301B Boehringer Ingelheim Investigational Site
      • Rennes, France
        • 205.339.3318A Boehringer Ingelheim Investigational Site
      • Rennes, France
        • 205.339.3318C Boehringer Ingelheim Investigational Site
      • Rennes, France
        • 205.339.3318G Boehringer Ingelheim Investigational Site
      • Roscoff Cedex, France
        • 205.339.3315C Boehringer Ingelheim Investigational Site
      • Roscoff Cedex, France
        • 205.339.3315D Boehringer Ingelheim Investigational Site
      • Rouen cedex, France
        • 205.339.3306A Boehringer Ingelheim Investigational Site
      • Rouen cedex, France
        • 205.339.3306B Boehringer Ingelheim Investigational Site
      • Rouen cedex, France
        • 205.339.3307A Boehringer Ingelheim Investigational Site
      • Vandoeuvre les Nancy, France
        • 205.339.3309A Boehringer Ingelheim Investigational Site
      • Vannes, France
        • 205.339.3316A Boehringer Ingelheim Investigational Site
  • Germany
      • Erlangen, Germany
        • 205.339.49132 Boehringer Ingelheim Investigational Site
      • Frankfurt, Germany
        • 205.339.49137 Boehringer Ingelheim Investigational Site
      • Frankfurt/Main, Germany
        • 205.339.49133 Boehringer Ingelheim Investigational Site
      • Freiburg, Germany
        • 205.339.49134 Boehringer Ingelheim Investigational Site
      • Gerlingen, Germany
        • 205.339.49131 Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • 205.339.49145 Boehringer Ingelheim Investigational Site
      • Hannover, Germany
        • 205.339.49135 Boehringer Ingelheim Investigational Site
      • Heidelberg, Germany
        • 205.339.49141 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 205.339.49140 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 205.339.49142 Boehringer Ingelheim Investigational Site
      • Tübingen, Germany
        • 205.339.49130 Boehringer Ingelheim Investigational Site
  • Italy
      • Ancona, Italy
        • 205.339.233 Boehringer Ingelheim Investigational Site
      • Firenze, Italy
        • 205.339.231 Boehringer Ingelheim Investigational Site
      • Genova, Italy
        • 205.339.234 Boehringer Ingelheim Investigational Site
  • Netherlands
      • Groesbeek, Netherlands
        • 205.339.171 Boehringer Ingelheim Investigational Site
      • Rotterdam, Netherlands
        • 205.339.170 Boehringer Ingelheim Investigational Site
  • New Zealand
      • Grafton / Auckland, New Zealand
        • 205.339.105 Boehringer Ingelheim Investigational Site
      • Hamilton, New Zealand
        • 205.339.106 Boehringer Ingelheim Investigational Site
  • Portugal
      • Lisboa, Portugal
        • 205.339.221 Boehringer Ingelheim Investigational Site
      • Lisboa, Portugal
        • 205.339.225 Boehringer Ingelheim Investigational Site
      • Porto, Portugal
        • 205.339.223 Boehringer Ingelheim Investigational Site
      • Porto, Portugal
        • 205.339.224 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Moscow, Russian Federation
        • 205.339.07001 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 205.339.07002 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 205.339.07003 Boehringer Ingelheim Investigational Site
      • Rostov-on-Don, Russian Federation
        • 205.339.07007 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 205.339.07005 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 205.339.07006 Boehringer Ingelheim Investigational Site
      • Voronezh, Russian Federation
        • 205.339.07008 Boehringer Ingelheim Investigational Site
      • Yaroslavl, Russian Federation
        • 205.339.07004 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Belfast, United Kingdom
        • 205.339.44180 Boehringer Ingelheim Investigational Site
      • Birmingham, United Kingdom
        • 205.339.44190 Boehringer Ingelheim Investigational Site
      • Boston, United Kingdom
        • 205.339.44193 Boehringer Ingelheim Investigational Site
      • Leeds, United Kingdom
        • 205.339.44192 Boehringer Ingelheim Investigational Site
      • Lincoln, United Kingdom
        • 205.339.44191 Boehringer Ingelheim Investigational Site
      • Liverpool, United Kingdom
        • 205.339.44185 Boehringer Ingelheim Investigational Site
      • Liverpool, United Kingdom
        • 205.339.44186 Boehringer Ingelheim Investigational Site
      • Nottingham, United Kingdom
        • 205.339.44183 Boehringer Ingelheim Investigational Site
      • Oxford, United Kingdom
        • 205.339.44182 Boehringer Ingelheim Investigational Site
      • Plymouth, United Kingdom
        • 205.339.44194 Boehringer Ingelheim Investigational Site
      • Sheffield, United Kingdom
        • 205.339.44181 Boehringer Ingelheim Investigational Site
      • Wolverhampton, United Kingdom
        • 205.339.44184 Boehringer Ingelheim Investigational Site
  • United States
    • Arizona
      • Tucson, Arizona, United States
        • 205.339.006 Boehringer Ingelheim Investigational Site
    • California
      • San Diego, California, United States
        • 205.339.019 Boehringer Ingelheim Investigational Site
    • Florida
      • Jacksonville, Florida, United States
        • 205.339.023 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 205.339.021 Boehringer Ingelheim Investigational Site
      • Orlando, Florida, United States
        • 205.339.030 Boehringer Ingelheim Investigational Site
      • Orlando, Florida, United States
        • 205.339.031 Boehringer Ingelheim Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States
        • 205.339.014 Boehringer Ingelheim Investigational Site
      • Indianapolis, Indiana, United States
        • 205.339.022 Boehringer Ingelheim Investigational Site
      • South Bend, Indiana, United States
        • 205.339.013 Boehringer Ingelheim Investigational Site
    • Iowa
      • Iowa City, Iowa, United States
        • 205.339.001 Boehringer Ingelheim Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • 205.339.017 Boehringer Ingelheim Investigational Site
      • Detroit, Michigan, United States
        • 205.339.025 Boehringer Ingelheim Investigational Site
      • Grand Rapids, Michigan, United States
        • 205.339.016 Boehringer Ingelheim Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • 205.339.018 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Long Branch, New Jersey, United States
        • 205.339.029 Boehringer Ingelheim Investigational Site
      • Morristown, New Jersey, United States
        • 205.339.009 Boehringer Ingelheim Investigational Site
    • New York
      • Syracuse, New York, United States
        • 205.339.002 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cleveland, Ohio, United States
        • 205.339.024 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 205.339.020 Boehringer Ingelheim Investigational Site
      • Oklahoma City, Oklahoma, United States
        • 205.339.032 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States
        • 205.339.010 Boehringer Ingelheim Investigational Site
    • Texas
      • Fort Worth, Texas, United States
        • 205.339.004 Boehringer Ingelheim Investigational Site
    • Utah
      • Salt Lake City, Utah, United States
        • 205.339.005 Boehringer Ingelheim Investigational Site
    • Vermont
      • Colchester, Vermont, United States
        • 205.339.026 Boehringer Ingelheim Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States
        • 205.339.011 Boehringer Ingelheim Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • 205.339.003 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Male or female patients
  2. Diagnosis of Cystic Fibrosis (positive sweat chloride test or two identifiable mutations)
  3. Pre-bronchodilator FEV1 greater/equal 25% of predicted values

Exclusion criteria:

  1. Significant history of allergy/hypersensitivity
  2. Hypersensitivity to study drug
  3. Participation in another trial
  4. Female patients who are pregnant or lactating
  5. Female patients of childbearing potential
  6. Patients who have started a new medication for CF within 4 weeks of screening
  7. Patients with known substance abuse
  8. Clinically significant disease other than CF

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tiotropium Respimat 2.5 mcg
patient to receive low dose tiotropium once daily
Drug: tiotropium bromide-low dose-2.5mcg
patient to receive low dose tiotropium once daily
Experimental: Tiotropium Respimat 5 mcg
patient to receive high dose tiotropium once daily
Drug: Tiotropium bromide 5 mcg
patient to recieve high dose tiotropium once daily
Placebo Comparator: Placebo Respimat
patient to receive placebo once daily
Drug: Placebo Respimat
patient to receive placebo matching active drug once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Predicted FEV1 AUC0-4 Response at the End of Week 12
Time Frame: Baseline, Week 12
Outcome measure description: Change from baseline in percent predicted Forced Expiratory Volume in one second (FEV1) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline.
Baseline, Week 12
Percent Predicted FEV1 Trough Response at the End of Week 12
Time Frame: Baseline, Week 12
Outcome measure description: Change from baseline in percent predicted trough Forced Expiratory Volume in one second. Calculated as percent predicted at week 12 minus percent predicted at baseline.
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Predicted FVC AUC0-4 Response at the End of Week 12
Time Frame: Baseline, Week 12
Change from baseline in percent predicted Forced Vital Capacity (FVC) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline.
Baseline, Week 12
Percent Predicted FVC Trough Response at the End of Week 12
Time Frame: Baseline, Week 12
Change from baseline in percent predicted trough Forced Vital Capacity (FVC). Calculated as percent predicted at week 12 minus percent predicted at baseline.
Baseline, Week 12
Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12
Time Frame: Baseline, Week 12
Forced Expiratory Flow at 25-75% of vital capacity (FEF25-75). Calculated as percent predicted at week 12 minus percent predicted at baseline.
Baseline, Week 12
Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12
Time Frame: Baseline, Week 12
Change from baseline in static lung hyperinflation as measured by RV/TLC. Calculated as percent predicted at week 12 minus percent predicted at baseline.
Baseline, Week 12
Respiratory and Systemic Symptoms Questionnaire (RSSQ)
Time Frame: 12 weeks
Outcome measure description: The RSSQ questionnaire is used to determine the presence or absence of an exacerbation during the recall period.
12 weeks
Change From Baseline in CFQ Scores - Adult Group
Time Frame: 12 weeks
The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adults with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.
12 weeks
Change From Baseline in CFQ Scores - Adolescents Group
Time Frame: 12 weeks
The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents (age 6-13) with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.
12 weeks
Change From Baseline in CFQ Scores - Parent Questionnaire
Time Frame: 12 weeks
The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents with CF - parent questionnaire. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.
12 weeks
Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss)
Time Frame: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Ae0-4,ss represents the amount of tiotropium that is eliminated in urine from time 0 to 4 hours at steady state
pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Maximum Measured Concentration at Steady State (Cmax,ss)
Time Frame: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Cmax,ss represents the maximum measured concentration of tiotropium in plasma at steady state.
pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Time From Dosing to the Maximum Concentration (Tmax,ss)
Time Frame: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Tmax,ss represents the time from dosing to the maximum concentration of tiotropium in plasma
pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation
Time Frame: From first drug administration until 30 days after last drug administration (up to 121 days)
Clinical Relevant Abnormalities for Vital Signs and Laboratory evaluation. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Event.
From first drug administration until 30 days after last drug administration (up to 121 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

August 15, 2008

First Submitted That Met QC Criteria

August 15, 2008

First Posted (Estimate)

August 18, 2008

Study Record Updates

Last Update Posted (Estimate)

May 16, 2014

Last Update Submitted That Met QC Criteria

May 7, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.339
  • 2008-001156-43 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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