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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo Respimat
Tiotropium bromide 5 mcg
tiotropium bromide-low dose-2.5mcg
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 205.339.006 Boehringer Ingelheim Investigational Site
  • 205.339.019 Boehringer Ingelheim Investigational Site
  • 205.339.023 Boehringer Ingelheim Investigational Site
  • 205.339.021 Boehringer Ingelheim Investigational Site
  • 205.339.030 Boehringer Ingelheim Investigational Site
  • 205.339.031 Boehringer Ingelheim Investigational Site
  • 205.339.014 Boehringer Ingelheim Investigational Site
  • 205.339.022 Boehringer Ingelheim Investigational Site
  • 205.339.013 Boehringer Ingelheim Investigational Site
  • 205.339.001 Boehringer Ingelheim Investigational Site
  • 205.339.017 Boehringer Ingelheim Investigational Site
  • 205.339.025 Boehringer Ingelheim Investigational Site
  • 205.339.016 Boehringer Ingelheim Investigational Site
  • 205.339.018 Boehringer Ingelheim Investigational Site
  • 205.339.029 Boehringer Ingelheim Investigational Site
  • 205.339.009 Boehringer Ingelheim Investigational Site
  • 205.339.002 Boehringer Ingelheim Investigational Site
  • 205.339.024 Boehringer Ingelheim Investigational Site
  • 205.339.020 Boehringer Ingelheim Investigational Site
  • 205.339.032 Boehringer Ingelheim Investigational Site
  • 205.339.010 Boehringer Ingelheim Investigational Site
  • 205.339.004 Boehringer Ingelheim Investigational Site
  • 205.339.005 Boehringer Ingelheim Investigational Site
  • 205.339.026 Boehringer Ingelheim Investigational Site
  • 205.339.011 Boehringer Ingelheim Investigational Site
  • 205.339.003 Boehringer Ingelheim Investigational Site
  • 205.339.100 Boehringer Ingelheim Investigational Site
  • 205.339.101 Boehringer Ingelheim Investigational Site
  • 205.339.103 Boehringer Ingelheim Investigational Site
  • 205.339.104 Boehringer Ingelheim Investigational Site
  • 205.339.111 Boehringer Ingelheim Investigational Site
  • 205.339.112 Boehringer Ingelheim Investigational Site
  • 205.339.110 Boehringer Ingelheim Investigational Site
  • 205.339.3310A Boehringer Ingelheim Investigational Site
  • 205.339.3317A Boehringer Ingelheim Investigational Site
  • 205.339.3317C Boehringer Ingelheim Investigational Site
  • 205.339.3317D Boehringer Ingelheim Investigational Site
  • 205.339.3317E Boehringer Ingelheim Investigational Site
  • 205.339.3314A Boehringer Ingelheim Investigational Site
  • 205.339.3314B Boehringer Ingelheim Investigational Site
  • 205.339.3314C Boehringer Ingelheim Investigational Site
  • 205.339.3302A Boehringer Ingelheim Investigational Site
  • 205.339.3302C Boehringer Ingelheim Investigational Site
  • 205.339.3302B Boehringer Ingelheim Investigational Site
  • 205.339.3303A Boehringer Ingelheim Investigational Site
  • 205.339.3304A Boehringer Ingelheim Investigational Site
  • 205.339.3304B Boehringer Ingelheim Investigational Site
  • 205.339.3308A Boehringer Ingelheim Investigational Site
  • 205.339.3308B Boehringer Ingelheim Investigational Site
  • 205.339.3308C Boehringer Ingelheim Investigational Site
  • 205.339.3301B Boehringer Ingelheim Investigational Site
  • 205.339.3312A Boehringer Ingelheim Investigational Site
  • 205.339.3312C Boehringer Ingelheim Investigational Site
  • 205.339.3313A Boehringer Ingelheim Investigational Site
  • 205.339.3313B Boehringer Ingelheim Investigational Site
  • 205.339.3318A Boehringer Ingelheim Investigational Site
  • 205.339.3318C Boehringer Ingelheim Investigational Site
  • 205.339.3318G Boehringer Ingelheim Investigational Site
  • 205.339.3315C Boehringer Ingelheim Investigational Site
  • 205.339.3315D Boehringer Ingelheim Investigational Site
  • 205.339.3306A Boehringer Ingelheim Investigational Site
  • 205.339.3306B Boehringer Ingelheim Investigational Site
  • 205.339.3307A Boehringer Ingelheim Investigational Site
  • 205.339.3309A Boehringer Ingelheim Investigational Site
  • 205.339.3316A Boehringer Ingelheim Investigational Site
  • 205.339.49132 Boehringer Ingelheim Investigational Site
  • 205.339.49133 Boehringer Ingelheim Investigational Site
  • 205.339.49137 Boehringer Ingelheim Investigational Site
  • 205.339.49134 Boehringer Ingelheim Investigational Site
  • 205.339.49131 Boehringer Ingelheim Investigational Site
  • 205.339.49145 Boehringer Ingelheim Investigational Site
  • 205.339.49135 Boehringer Ingelheim Investigational Site
  • 205.339.49141 Boehringer Ingelheim Investigational Site
  • 205.339.49140 Boehringer Ingelheim Investigational Site
  • 205.339.49142 Boehringer Ingelheim Investigational Site
  • 205.339.49130 Boehringer Ingelheim Investigational Site
  • 205.339.233 Boehringer Ingelheim Investigational Site
  • 205.339.231 Boehringer Ingelheim Investigational Site
  • 205.339.234 Boehringer Ingelheim Investigational Site
  • 205.339.171 Boehringer Ingelheim Investigational Site
  • 205.339.170 Boehringer Ingelheim Investigational Site
  • 205.339.105 Boehringer Ingelheim Investigational Site
  • 205.339.106 Boehringer Ingelheim Investigational Site
  • 205.339.221 Boehringer Ingelheim Investigational Site
  • 205.339.225 Boehringer Ingelheim Investigational Site
  • 205.339.223 Boehringer Ingelheim Investigational Site
  • 205.339.224 Boehringer Ingelheim Investigational Site
  • 205.339.07001 Boehringer Ingelheim Investigational Site
  • 205.339.07002 Boehringer Ingelheim Investigational Site
  • 205.339.07003 Boehringer Ingelheim Investigational Site
  • 205.339.07007 Boehringer Ingelheim Investigational Site
  • 205.339.07005 Boehringer Ingelheim Investigational Site
  • 205.339.07006 Boehringer Ingelheim Investigational Site
  • 205.339.07008 Boehringer Ingelheim Investigational Site
  • 205.339.07004 Boehringer Ingelheim Investigational Site
  • 205.339.44180 Boehringer Ingelheim Investigational Site
  • 205.339.44190 Boehringer Ingelheim Investigational Site
  • 205.339.44193 Boehringer Ingelheim Investigational Site
  • 205.339.44192 Boehringer Ingelheim Investigational Site
  • 205.339.44191 Boehringer Ingelheim Investigational Site
  • 205.339.44185 Boehringer Ingelheim Investigational Site
  • 205.339.44186 Boehringer Ingelheim Investigational Site
  • 205.339.44183 Boehringer Ingelheim Investigational Site
  • 205.339.44182 Boehringer Ingelheim Investigational Site
  • 205.339.44194 Boehringer Ingelheim Investigational Site
  • 205.339.44181 Boehringer Ingelheim Investigational Site
  • 205.339.44184 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Tiotropium Respimat 2.5 mcg

Tiotropium Respimat 5 mcg

Placebo Respimat

Arm Description

patient to receive low dose tiotropium once daily

patient to receive high dose tiotropium once daily

patient to receive placebo once daily

Outcomes

Primary Outcome Measures

Percent Predicted FEV1 AUC0-4 Response at the End of 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.
Percent Predicted FEV1 Trough Response at the End of 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.

Secondary Outcome Measures

Percent Predicted FVC AUC0-4 Response at the End of 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.
Percent Predicted FVC Trough Response at the End of 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.
Pre-bronchodilator FEF25-75 Percent Predicted at the End of 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.
Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of 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.
Respiratory and Systemic Symptoms Questionnaire (RSSQ)
Outcome measure description: The RSSQ questionnaire is used to determine the presence or absence of an exacerbation during the recall period.
Change From Baseline in CFQ Scores - Adult Group
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.
Change From Baseline in CFQ Scores - Adolescents Group
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.
Change From Baseline in CFQ Scores - Parent Questionnaire
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.
Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss)
Ae0-4,ss represents the amount of tiotropium that is eliminated in urine from time 0 to 4 hours at steady state
Maximum Measured Concentration at Steady State (Cmax,ss)
Cmax,ss represents the maximum measured concentration of tiotropium in plasma at steady state.
Time From Dosing to the Maximum Concentration (Tmax,ss)
Tmax,ss represents the time from dosing to the maximum concentration of tiotropium in plasma
Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation
Clinical Relevant Abnormalities for Vital Signs and Laboratory evaluation. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Event.

Full Information

First Posted
August 15, 2008
Last Updated
May 7, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00737100
Brief Title
Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
510 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tiotropium Respimat 2.5 mcg
Arm Type
Experimental
Arm Description
patient to receive low dose tiotropium once daily
Arm Title
Tiotropium Respimat 5 mcg
Arm Type
Experimental
Arm Description
patient to receive high dose tiotropium once daily
Arm Title
Placebo Respimat
Arm Type
Placebo Comparator
Arm Description
patient to receive placebo once daily
Intervention Type
Drug
Intervention Name(s)
Placebo Respimat
Intervention Description
patient to receive placebo matching active drug once daily
Intervention Type
Drug
Intervention Name(s)
Tiotropium bromide 5 mcg
Intervention Description
patient to recieve high dose tiotropium once daily
Intervention Type
Drug
Intervention Name(s)
tiotropium bromide-low dose-2.5mcg
Intervention Description
patient to receive low dose tiotropium once daily
Primary Outcome Measure Information:
Title
Percent Predicted FEV1 AUC0-4 Response at the End of Week 12
Description
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.
Time Frame
Baseline, Week 12
Title
Percent Predicted FEV1 Trough Response at the End of Week 12
Description
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.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Percent Predicted FVC AUC0-4 Response at the End of Week 12
Description
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.
Time Frame
Baseline, Week 12
Title
Percent Predicted FVC Trough Response at the End of Week 12
Description
Change from baseline in percent predicted trough Forced Vital Capacity (FVC). Calculated as percent predicted at week 12 minus percent predicted at baseline.
Time Frame
Baseline, Week 12
Title
Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12
Description
Forced Expiratory Flow at 25-75% of vital capacity (FEF25-75). Calculated as percent predicted at week 12 minus percent predicted at baseline.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12
Description
Change from baseline in static lung hyperinflation as measured by RV/TLC. Calculated as percent predicted at week 12 minus percent predicted at baseline.
Time Frame
Baseline, Week 12
Title
Respiratory and Systemic Symptoms Questionnaire (RSSQ)
Description
Outcome measure description: The RSSQ questionnaire is used to determine the presence or absence of an exacerbation during the recall period.
Time Frame
12 weeks
Title
Change From Baseline in CFQ Scores - Adult Group
Description
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.
Time Frame
12 weeks
Title
Change From Baseline in CFQ Scores - Adolescents Group
Description
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.
Time Frame
12 weeks
Title
Change From Baseline in CFQ Scores - Parent Questionnaire
Description
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.
Time Frame
12 weeks
Title
Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss)
Description
Ae0-4,ss represents the amount of tiotropium that is eliminated in urine from time 0 to 4 hours at steady state
Time Frame
pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Title
Maximum Measured Concentration at Steady State (Cmax,ss)
Description
Cmax,ss represents the maximum measured concentration of tiotropium in plasma at steady state.
Time Frame
pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Title
Time From Dosing to the Maximum Concentration (Tmax,ss)
Description
Tmax,ss represents the time from dosing to the maximum concentration of tiotropium in plasma
Time Frame
pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Title
Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation
Description
Clinical Relevant Abnormalities for Vital Signs and Laboratory evaluation. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Event.
Time Frame
From first drug administration until 30 days after last drug administration (up to 121 days)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Male or female patients Diagnosis of Cystic Fibrosis (positive sweat chloride test or two identifiable mutations) Pre-bronchodilator FEV1 greater/equal 25% of predicted values Exclusion criteria: Significant history of allergy/hypersensitivity Hypersensitivity to study drug Participation in another trial Female patients who are pregnant or lactating Female patients of childbearing potential Patients who have started a new medication for CF within 4 weeks of screening Patients with known substance abuse Clinically significant disease other than CF
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
205.339.006 Boehringer Ingelheim Investigational Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
205.339.019 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
205.339.023 Boehringer Ingelheim Investigational Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
205.339.021 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
205.339.030 Boehringer Ingelheim Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
205.339.031 Boehringer Ingelheim Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
205.339.014 Boehringer Ingelheim Investigational Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
205.339.022 Boehringer Ingelheim Investigational Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
205.339.013 Boehringer Ingelheim Investigational Site
City
South Bend
State/Province
Indiana
Country
United States
Facility Name
205.339.001 Boehringer Ingelheim Investigational Site
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
205.339.017 Boehringer Ingelheim Investigational Site
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
205.339.025 Boehringer Ingelheim Investigational Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
205.339.016 Boehringer Ingelheim Investigational Site
City
Grand Rapids
State/Province
Michigan
Country
United States
Facility Name
205.339.018 Boehringer Ingelheim Investigational Site
City
Lebanon
State/Province
New Hampshire
Country
United States
Facility Name
205.339.029 Boehringer Ingelheim Investigational Site
City
Long Branch
State/Province
New Jersey
Country
United States
Facility Name
205.339.009 Boehringer Ingelheim Investigational Site
City
Morristown
State/Province
New Jersey
Country
United States
Facility Name
205.339.002 Boehringer Ingelheim Investigational Site
City
Syracuse
State/Province
New York
Country
United States
Facility Name
205.339.024 Boehringer Ingelheim Investigational Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
205.339.020 Boehringer Ingelheim Investigational Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
205.339.032 Boehringer Ingelheim Investigational Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
205.339.010 Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
205.339.004 Boehringer Ingelheim Investigational Site
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
205.339.005 Boehringer Ingelheim Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
205.339.026 Boehringer Ingelheim Investigational Site
City
Colchester
State/Province
Vermont
Country
United States
Facility Name
205.339.011 Boehringer Ingelheim Investigational Site
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
205.339.003 Boehringer Ingelheim Investigational Site
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
205.339.100 Boehringer Ingelheim Investigational Site
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
205.339.101 Boehringer Ingelheim Investigational Site
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
205.339.103 Boehringer Ingelheim Investigational Site
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
205.339.104 Boehringer Ingelheim Investigational Site
City
Subiaco
State/Province
Western Australia
Country
Australia
Facility Name
205.339.111 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
205.339.112 Boehringer Ingelheim Investigational Site
City
Jette
Country
Belgium
Facility Name
205.339.110 Boehringer Ingelheim Investigational Site
City
Leuven
Country
Belgium
Facility Name
205.339.3310A Boehringer Ingelheim Investigational Site
City
Amiens
Country
France
Facility Name
205.339.3317A Boehringer Ingelheim Investigational Site
City
Angers
Country
France
Facility Name
205.339.3317C Boehringer Ingelheim Investigational Site
City
Angers
Country
France
Facility Name
205.339.3317D Boehringer Ingelheim Investigational Site
City
Angers
Country
France
Facility Name
205.339.3317E Boehringer Ingelheim Investigational Site
City
Angers
Country
France
Facility Name
205.339.3314A Boehringer Ingelheim Investigational Site
City
BRON Cedex
Country
France
Facility Name
205.339.3314B Boehringer Ingelheim Investigational Site
City
BRON Cedex
Country
France
Facility Name
205.339.3314C Boehringer Ingelheim Investigational Site
City
BRON Cedex
Country
France
Facility Name
205.339.3302A Boehringer Ingelheim Investigational Site
City
Lille Cedex
Country
France
Facility Name
205.339.3302C Boehringer Ingelheim Investigational Site
City
Lille Cedex
Country
France
Facility Name
205.339.3302B Boehringer Ingelheim Investigational Site
City
Lille
Country
France
Facility Name
205.339.3303A Boehringer Ingelheim Investigational Site
City
Lisieux
Country
France
Facility Name
205.339.3304A Boehringer Ingelheim Investigational Site
City
Montpellier
Country
France
Facility Name
205.339.3304B Boehringer Ingelheim Investigational Site
City
Montpellier
Country
France
Facility Name
205.339.3308A Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
205.339.3308B Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
205.339.3308C Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
205.339.3301B Boehringer Ingelheim Investigational Site
City
Paris Cedex 14
Country
France
Facility Name
205.339.3312A Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
205.339.3312C Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
205.339.3313A Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
205.339.3313B Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
205.339.3318A Boehringer Ingelheim Investigational Site
City
Rennes
Country
France
Facility Name
205.339.3318C Boehringer Ingelheim Investigational Site
City
Rennes
Country
France
Facility Name
205.339.3318G Boehringer Ingelheim Investigational Site
City
Rennes
Country
France
Facility Name
205.339.3315C Boehringer Ingelheim Investigational Site
City
Roscoff Cedex
Country
France
Facility Name
205.339.3315D Boehringer Ingelheim Investigational Site
City
Roscoff Cedex
Country
France
Facility Name
205.339.3306A Boehringer Ingelheim Investigational Site
City
Rouen cedex
Country
France
Facility Name
205.339.3306B Boehringer Ingelheim Investigational Site
City
Rouen cedex
Country
France
Facility Name
205.339.3307A Boehringer Ingelheim Investigational Site
City
Rouen cedex
Country
France
Facility Name
205.339.3309A Boehringer Ingelheim Investigational Site
City
Vandoeuvre les Nancy
Country
France
Facility Name
205.339.3316A Boehringer Ingelheim Investigational Site
City
Vannes
Country
France
Facility Name
205.339.49132 Boehringer Ingelheim Investigational Site
City
Erlangen
Country
Germany
Facility Name
205.339.49133 Boehringer Ingelheim Investigational Site
City
Frankfurt/Main
Country
Germany
Facility Name
205.339.49137 Boehringer Ingelheim Investigational Site
City
Frankfurt
Country
Germany
Facility Name
205.339.49134 Boehringer Ingelheim Investigational Site
City
Freiburg
Country
Germany
Facility Name
205.339.49131 Boehringer Ingelheim Investigational Site
City
Gerlingen
Country
Germany
Facility Name
205.339.49145 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
205.339.49135 Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
205.339.49141 Boehringer Ingelheim Investigational Site
City
Heidelberg
Country
Germany
Facility Name
205.339.49140 Boehringer Ingelheim Investigational Site
City
München
Country
Germany
Facility Name
205.339.49142 Boehringer Ingelheim Investigational Site
City
München
Country
Germany
Facility Name
205.339.49130 Boehringer Ingelheim Investigational Site
City
Tübingen
Country
Germany
Facility Name
205.339.233 Boehringer Ingelheim Investigational Site
City
Ancona
Country
Italy
Facility Name
205.339.231 Boehringer Ingelheim Investigational Site
City
Firenze
Country
Italy
Facility Name
205.339.234 Boehringer Ingelheim Investigational Site
City
Genova
Country
Italy
Facility Name
205.339.171 Boehringer Ingelheim Investigational Site
City
Groesbeek
Country
Netherlands
Facility Name
205.339.170 Boehringer Ingelheim Investigational Site
City
Rotterdam
Country
Netherlands
Facility Name
205.339.105 Boehringer Ingelheim Investigational Site
City
Grafton / Auckland
Country
New Zealand
Facility Name
205.339.106 Boehringer Ingelheim Investigational Site
City
Hamilton
Country
New Zealand
Facility Name
205.339.221 Boehringer Ingelheim Investigational Site
City
Lisboa
Country
Portugal
Facility Name
205.339.225 Boehringer Ingelheim Investigational Site
City
Lisboa
Country
Portugal
Facility Name
205.339.223 Boehringer Ingelheim Investigational Site
City
Porto
Country
Portugal
Facility Name
205.339.224 Boehringer Ingelheim Investigational Site
City
Porto
Country
Portugal
Facility Name
205.339.07001 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
205.339.07002 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
205.339.07003 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
205.339.07007 Boehringer Ingelheim Investigational Site
City
Rostov-on-Don
Country
Russian Federation
Facility Name
205.339.07005 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
205.339.07006 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
205.339.07008 Boehringer Ingelheim Investigational Site
City
Voronezh
Country
Russian Federation
Facility Name
205.339.07004 Boehringer Ingelheim Investigational Site
City
Yaroslavl
Country
Russian Federation
Facility Name
205.339.44180 Boehringer Ingelheim Investigational Site
City
Belfast
Country
United Kingdom
Facility Name
205.339.44190 Boehringer Ingelheim Investigational Site
City
Birmingham
Country
United Kingdom
Facility Name
205.339.44193 Boehringer Ingelheim Investigational Site
City
Boston
Country
United Kingdom
Facility Name
205.339.44192 Boehringer Ingelheim Investigational Site
City
Leeds
Country
United Kingdom
Facility Name
205.339.44191 Boehringer Ingelheim Investigational Site
City
Lincoln
Country
United Kingdom
Facility Name
205.339.44185 Boehringer Ingelheim Investigational Site
City
Liverpool
Country
United Kingdom
Facility Name
205.339.44186 Boehringer Ingelheim Investigational Site
City
Liverpool
Country
United Kingdom
Facility Name
205.339.44183 Boehringer Ingelheim Investigational Site
City
Nottingham
Country
United Kingdom
Facility Name
205.339.44182 Boehringer Ingelheim Investigational Site
City
Oxford
Country
United Kingdom
Facility Name
205.339.44194 Boehringer Ingelheim Investigational Site
City
Plymouth
Country
United Kingdom
Facility Name
205.339.44181 Boehringer Ingelheim Investigational Site
City
Sheffield
Country
United Kingdom
Facility Name
205.339.44184 Boehringer Ingelheim Investigational Site
City
Wolverhampton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25819269
Citation
Ratjen F, Koker P, Geller DE, Langellier-Cocteaux B, Le Maulf F, Kattenbeck S, Moroni-Zentgraf P, Elborn JS; Tiotropium Cystic Fibrosis Study Group. Tiotropium Respimat in cystic fibrosis: Phase 3 and Pooled phase 2/3 randomized trials. J Cyst Fibros. 2015 Sep;14(5):608-14. doi: 10.1016/j.jcf.2015.03.004. Epub 2015 Mar 26.
Results Reference
derived
PubMed Identifier
25188297
Citation
Bradley JM, Koker P, Deng Q, Moroni-Zentgraf P, Ratjen F, Geller DE, Elborn JS; Tiotropium Cystic Fibrosis Study Group. Testing two different doses of tiotropium Respimat(R) in cystic fibrosis: phase 2 randomized trial results. PLoS One. 2014 Sep 4;9(9):e106195. doi: 10.1371/journal.pone.0106195. eCollection 2014.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.339_U11-3096-02-DS.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.339_Literature.pdf
Description
Related Info

Learn more about this trial

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

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