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Tiotropium Bromide in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tiotropium Respimat® inhaler
Placebo Respimat® inhaler
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. Patients with a documented diagnosis of Cystic Fibrosis (CF) (positive sweat chloride >=60 mEq/liter, by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations.
  2. Male or female patients (children less than 12 years and adolescents >12 years).
  3. Patients >=5 years of age must be able to perform acceptable spirometric maneuvers, according to the American Thoracic Society (ATS) standards.
  4. Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) >25% of predicted values.
  5. Pre-bronchodilator FEV1 at Visit 2 must be within 15% of FEV1 at Visit 1.
  6. No evidence of respiratory tract infection and no pulmonary exacerbation requiring use of intravenous/oral/inhaled antibiotics, or oral corticosteroids within 2 weeks of screening.
  7. The patient or the patient's legally acceptable representative must be able to give informed consent.
  8. Patients who are on a cycling TOBI® regimen must have completed at least 2 cycles every other month TOBI® administration prior to the screening visit.
  9. Patients who are on daily inhaled antibiotic use must be stabilized for at least 6 weeks prior to Visit 1 (screening).
  10. Patients having previously participated in study 205.339 can also be selected.

Exclusion criteria:

  1. Patients with a known hypersensitivity to study drug
  2. Patients who have participated in another study with an Investigational drug within one month preceding the screening visit.
  3. Patients who are currently participating in another trial. Observational studies are allowed. Permission should be obtained from sponsor of other study.
  4. Patients with known relevant substance abuse, including alcohol or drug abuse.
  5. Adolescent and adult female patients who are pregnant or lactating, including females who have a positive serum pregnancy test at screening.
  6. Female patients of child bearing potential who are not using a medically approved form of contraception.
  7. Clinically significant disease or medical condition other than CF or CF-related conditions that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. Patients with diabetes may participate if their disease is under good control prior to screening.

Sites / Locations

  • 205.438.01004 Boehringer Ingelheim Investigational Site
  • 205.438.01011 Boehringer Ingelheim Investigational Site
  • 205.438.01018 Boehringer Ingelheim Investigational Site
  • 205.438.01008 Boehringer Ingelheim Investigational Site
  • 205.438.01014 Boehringer Ingelheim Investigational Site
  • 205.438.01021 Boehringer Ingelheim Investigational Site
  • 205.438.01007 Boehringer Ingelheim Investigational Site
  • 205.438.01006 Boehringer Ingelheim Investigational Site
  • 205.438.01001 Boehringer Ingelheim Investigational Site
  • 205.438.01010 Boehringer Ingelheim Investigational Site
  • 205.438.01003 Boehringer Ingelheim Investigational Site
  • 205.438.01019 Boehringer Ingelheim Investigational Site
  • 205.438.01013 Boehringer Ingelheim Investigational Site
  • 205.438.01005 Boehringer Ingelheim Investigational Site
  • 205.438.01012 Boehringer Ingelheim Investigational Site
  • 205.438.61003 Boehringer Ingelheim Investigational Site
  • 205.438.61004 Boehringer Ingelheim Investigational Site
  • 205.438.61001 Boehringer Ingelheim Investigational Site
  • 205.438.61002 Boehringer Ingelheim Investigational Site
  • 205.438.43001 Boehringer Ingelheim Investigational Site
  • 205.438.43002 Boehringer Ingelheim Investigational Site
  • 205.438.32002 Boehringer Ingelheim Investigational Site
  • 205.438.32004 Boehringer Ingelheim Investigational Site
  • 205.438.32003 Boehringer Ingelheim Investigational Site
  • 205.438.32001 Boehringer Ingelheim Investigational Site
  • 205.438.02005 Boehringer Ingelheim Investigational Site
  • 205.438.02007 Boehringer Ingelheim Investigational Site
  • 205.438.02004 Boehringer Ingelheim Investigational Site
  • 205.438.02003 Boehringer Ingelheim Investigational Site
  • 205.438.02006 Boehringer Ingelheim Investigational Site
  • 205.438.02001 Boehringer Ingelheim Investigational Site
  • 205.438.42002 Boehringer Ingelheim Investigational Site
  • 205.438.42003 Boehringer Ingelheim Investigational Site
  • 205.438.42004 Boehringer Ingelheim Investigational Site
  • 205.438.42001 Boehringer Ingelheim Investigational Site
  • 205.438.33010 Boehringer Ingelheim Investigational Site
  • 205.438.33013 Boehringer Ingelheim Investigational Site
  • 205.438.33002 Boehringer Ingelheim Investigational Site
  • 205.438.33015 Boehringer Ingelheim Investigational Site
  • 205.438.33003 Boehringer Ingelheim Investigational Site
  • 205.438.33005 Boehringer Ingelheim Investigational Site
  • 205.438.33014 Boehringer Ingelheim Investigational Site
  • 205.438.33001 Boehringer Ingelheim Investigational Site
  • 205.438.33006 Boehringer Ingelheim Investigational Site
  • 205.438.33007 Boehringer Ingelheim Investigational Site
  • 205.438.33011 Boehringer Ingelheim Investigational Site
  • 205.438.33008 Boehringer Ingelheim Investigational Site
  • 205.438.33004 Boehringer Ingelheim Investigational Site
  • 205.438.33009 Boehringer Ingelheim Investigational Site
  • 205.438.49001 Boehringer Ingelheim Investigational Site
  • 205.438.49011 Boehringer Ingelheim Investigational Site
  • 205.438.49002 Boehringer Ingelheim Investigational Site
  • 205.438.49012 Boehringer Ingelheim Investigational Site
  • 205.438.49006 Boehringer Ingelheim Investigational Site
  • 205.438.49007 Boehringer Ingelheim Investigational Site
  • 205.438.49005 Boehringer Ingelheim Investigational Site
  • 205.438.49003 Boehringer Ingelheim Investigational Site
  • 205.438.49008 Boehringer Ingelheim Investigational Site
  • 205.438.36002 Boehringer Ingelheim Investigational Site
  • 205.438.36003 Boehringer Ingelheim Investigational Site
  • 205.438.36004 Boehringer Ingelheim Investigational Site
  • 205.438.35301 Boehringer Ingelheim Investigational Site
  • 205.438.97003 Boehringer Ingelheim Investigational Site
  • 205.438.97001 Boehringer Ingelheim Investigational Site
  • 205.438.97002 Boehringer Ingelheim Investigational Site
  • 205.438.97004 Boehringer Ingelheim Investigational Site
  • 205.438.39001 Boehringer Ingelheim Investigational Site
  • 205.438.39003 Boehringer Ingelheim Investigational Site
  • 205.438.39002 Boehringer Ingelheim Investigational Site
  • 205.438.48001 Boehringer Ingelheim Investigational Site
  • 205.438.48002 Boehringer Ingelheim Investigational Site
  • 205.438.48003 Boehringer Ingelheim Investigational Site
  • 205.438.35001 Boehringer Ingelheim Investigational Site
  • 205.438.35002 Boehringer Ingelheim Investigational Site
  • 205.438.35003 Boehringer Ingelheim Investigational Site
  • 205.438.35004 Boehringer Ingelheim Investigational Site
  • 205.438.07001 Boehringer Ingelheim Investigational Site
  • 205.438.07005 Boehringer Ingelheim Investigational Site
  • 205.438.07003 Boehringer Ingelheim Investigational Site
  • 205.438.07004 Boehringer Ingelheim Investigational Site
  • 205.438.07002 Boehringer Ingelheim Investigational Site
  • 205.438.42102 Boehringer Ingelheim Investigational Site
  • 205.438.42101 Boehringer Ingelheim Investigational Site
  • 205.438.42103 Boehringer Ingelheim Investigational Site
  • 205.438.27001 Boehringer Ingelheim Investigational Site
  • 205.438.34005 Boehringer Ingelheim Investigational Site
  • 205.438.34001 Boehringer Ingelheim Investigational Site
  • 205.438.34002 Boehringer Ingelheim Investigational Site
  • 205.438.34004 Boehringer Ingelheim Investigational Site
  • 205.438.41003 Boehringer Ingelheim Investigational Site
  • 205.438.41004 Boehringer Ingelheim Investigational Site
  • 205.438.41001 Boehringer Ingelheim Investigational Site
  • 205.438.41002 Boehringer Ingelheim Investigational Site
  • 205.438.44009 Boehringer Ingelheim Investigational Site
  • 205.438.44007 Boehringer Ingelheim Investigational Site
  • 205.438.44004 Boehringer Ingelheim Investigational Site
  • 205.438.44005 Boehringer Ingelheim Investigational Site
  • 205.438.44002 Boehringer Ingelheim Investigational Site
  • 205.438.44003 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tiotropium

placebo

Arm Description

2 inhalations once daily delivered with Respimat® inhaler

2 inhalations once daily delivered with Respimat® inhaler

Outcomes

Primary Outcome Measures

Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0-4 Hours (AUC0-4h) Response
Mixed Model Repeated Measurement (MMRM) results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction. FEV1 AUC0-4h was normalised for time and was calculated using the trapezoidal rule divided by the observation time (4 h).
Trough FEV1 Response
MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Trough FEV1 was defined as the pre-dose FEV1 measured just prior to the administration of randomised treatment. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.

Secondary Outcome Measures

Forced Vital Capacity (FVC) Area Under the Curve 0-4 Hours (AUC0-4h) Response
MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction. FVC AUC0-4h was normalised for time and was calculated using the trapezoidal rule divided by the observation time (4 h).
Trough FVC Response
MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Trough FCV was defined as the pre-dose FVC measured just prior to the administration of randomised treatment. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.
Pre-bronchodilator Forced Expiratory Flow Between 25 Percent and 75 Percent of the FVC (FEF25-75) Response
MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. FEF25-75 is also known as maximum mid-expiratory flow and was measured before bronchodilator (salbutamol) use. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.
Percentage of Participants With at Least 1 Pulmonary Exacerbation During Double-blind Treatment
Selected questions from the Respiratory and Systemic Symptoms Questionnaire (RSSQ), the investigator assessment of physical findings and pulmonary function, and the use of intravenous antibiotics as a concomitant therapy were used to determine if a cystic fibrosis-related pulmonary exacerbation had occurred.
Change From Baseline in Revised Cystic Fibrosis Questionnaire (CFQ-R) Score
Different format of CFQ-R are used depending of the patients' age. Adolescent and adult format of CFQ-R is used for patients of 14 years and older, for younger children a parent version and a children format is used. In case parent and children questionnaires were filled out, the children questionnaire is taken into account. Scores were calculated for each domain of the CFQ-R which are presented separately. A score of 100 corresponds to the highest quality of life possible, whereas a score of 0 corresponds to the lowest quality of life possible. Increasing score indicates better health.

Full Information

First Posted
August 10, 2010
Last Updated
November 27, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01179347
Brief Title
Tiotropium Bromide in Cystic Fibrosis
Official Title
A Randomised, Double-blind, Placebo-controlled Parallel-group Trial to Confirm the Efficacy After 12 Weeks and the Safety of Tiotropium 5 Mcg Administered Once Daily Via the Respimat® Device in Patients With Cystic Fibrosis.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
To date, there have been no formal clinical studies completed using tiotropium in CF patients. While there is a large body of evidence demonstrating the efficacy and safety of tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD), relatively little is known about its efficacy and safety in patients with a diagnosis of cystic fibrosis. Therefore, Boehringer Ingelheim proposed to profile the long acting anticholinergic tiotropium and to generate adequate clinical data for use as a bronchodilator in paediatric and adult CF. The phase III trial (205.438) is a part of the approved Paediatric Investigation Plan (PIP) agreed for Spiriva® Respimat® in Cystic Fibrosis.

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 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
464 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tiotropium
Arm Type
Experimental
Arm Description
2 inhalations once daily delivered with Respimat® inhaler
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
2 inhalations once daily delivered with Respimat® inhaler
Intervention Type
Drug
Intervention Name(s)
tiotropium Respimat® inhaler
Intervention Description
to evaluate safety and efficacy tiotropium delivered with Respimat® inhaler compared to placebo.
Intervention Type
Drug
Intervention Name(s)
Placebo Respimat® inhaler
Intervention Description
patient to receive placebo matching active drug once daily
Primary Outcome Measure Information:
Title
Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0-4 Hours (AUC0-4h) Response
Description
Mixed Model Repeated Measurement (MMRM) results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction. FEV1 AUC0-4h was normalised for time and was calculated using the trapezoidal rule divided by the observation time (4 h).
Time Frame
30 minutes (min) before first dosing of study drug (defined as baseline), at 1 hour (h), 2 h , 3 h, and 4 h post dosing at day 1 and at 30 min before dosing, at 1 hour, 2 h , 3 h, and 4 h post dosing after 12 weeks.
Title
Trough FEV1 Response
Description
MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Trough FEV1 was defined as the pre-dose FEV1 measured just prior to the administration of randomised treatment. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Forced Vital Capacity (FVC) Area Under the Curve 0-4 Hours (AUC0-4h) Response
Description
MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction. FVC AUC0-4h was normalised for time and was calculated using the trapezoidal rule divided by the observation time (4 h).
Time Frame
30 minutes (min) before first dosing of study drug (defined as baseline), at 1 hour (h), 2 h , 3 h, and 4 h post dosing at day 1 and at 30 min before dosing, at 1 hour, 2 h , 3 h, and 4 h post dosing after 12 weeks.
Title
Trough FVC Response
Description
MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Trough FCV was defined as the pre-dose FVC measured just prior to the administration of randomised treatment. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.
Time Frame
Baseline and 12 weeks
Title
Pre-bronchodilator Forced Expiratory Flow Between 25 Percent and 75 Percent of the FVC (FEF25-75) Response
Description
MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. FEF25-75 is also known as maximum mid-expiratory flow and was measured before bronchodilator (salbutamol) use. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.
Time Frame
Baseline and 12 weeks
Title
Percentage of Participants With at Least 1 Pulmonary Exacerbation During Double-blind Treatment
Description
Selected questions from the Respiratory and Systemic Symptoms Questionnaire (RSSQ), the investigator assessment of physical findings and pulmonary function, and the use of intravenous antibiotics as a concomitant therapy were used to determine if a cystic fibrosis-related pulmonary exacerbation had occurred.
Time Frame
12 weeks
Title
Change From Baseline in Revised Cystic Fibrosis Questionnaire (CFQ-R) Score
Description
Different format of CFQ-R are used depending of the patients' age. Adolescent and adult format of CFQ-R is used for patients of 14 years and older, for younger children a parent version and a children format is used. In case parent and children questionnaires were filled out, the children questionnaire is taken into account. Scores were calculated for each domain of the CFQ-R which are presented separately. A score of 100 corresponds to the highest quality of life possible, whereas a score of 0 corresponds to the lowest quality of life possible. Increasing score indicates better health.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients with a documented diagnosis of Cystic Fibrosis (CF) (positive sweat chloride >=60 mEq/liter, by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations. Male or female patients (children less than 12 years and adolescents >12 years). Patients >=5 years of age must be able to perform acceptable spirometric maneuvers, according to the American Thoracic Society (ATS) standards. Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) >25% of predicted values. Pre-bronchodilator FEV1 at Visit 2 must be within 15% of FEV1 at Visit 1. No evidence of respiratory tract infection and no pulmonary exacerbation requiring use of intravenous/oral/inhaled antibiotics, or oral corticosteroids within 2 weeks of screening. The patient or the patient's legally acceptable representative must be able to give informed consent. Patients who are on a cycling TOBI® regimen must have completed at least 2 cycles every other month TOBI® administration prior to the screening visit. Patients who are on daily inhaled antibiotic use must be stabilized for at least 6 weeks prior to Visit 1 (screening). Patients having previously participated in study 205.339 can also be selected. Exclusion criteria: Patients with a known hypersensitivity to study drug Patients who have participated in another study with an Investigational drug within one month preceding the screening visit. Patients who are currently participating in another trial. Observational studies are allowed. Permission should be obtained from sponsor of other study. Patients with known relevant substance abuse, including alcohol or drug abuse. Adolescent and adult female patients who are pregnant or lactating, including females who have a positive serum pregnancy test at screening. Female patients of child bearing potential who are not using a medically approved form of contraception. Clinically significant disease or medical condition other than CF or CF-related conditions that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. Patients with diabetes may participate if their disease is under good control prior to screening.
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
205.438.01004 Boehringer Ingelheim Investigational Site
City
Tuscon
State/Province
Arizona
Country
United States
Facility Name
205.438.01011 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
205.438.01018 Boehringer Ingelheim Investigational Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
205.438.01008 Boehringer Ingelheim Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
205.438.01014 Boehringer Ingelheim Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
205.438.01021 Boehringer Ingelheim Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
205.438.01007 Boehringer Ingelheim Investigational Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
205.438.01006 Boehringer Ingelheim Investigational Site
City
South Bend
State/Province
Indiana
Country
United States
Facility Name
205.438.01001 Boehringer Ingelheim Investigational Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
205.438.01010 Boehringer Ingelheim Investigational Site
City
Manchester
State/Province
New Hampshire
Country
United States
Facility Name
205.438.01003 Boehringer Ingelheim Investigational Site
City
Syracuse
State/Province
New York
Country
United States
Facility Name
205.438.01019 Boehringer Ingelheim Investigational Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
205.438.01013 Boehringer Ingelheim Investigational Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
205.438.01005 Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
205.438.01012 Boehringer Ingelheim Investigational Site
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
205.438.61003 Boehringer Ingelheim Investigational Site
City
Chermside
State/Province
Queensland
Country
Australia
Facility Name
205.438.61004 Boehringer Ingelheim Investigational Site
City
Herston
State/Province
Queensland
Country
Australia
Facility Name
205.438.61001 Boehringer Ingelheim Investigational Site
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
205.438.61002 Boehringer Ingelheim Investigational Site
City
Subiaco
State/Province
Western Australia
Country
Australia
Facility Name
205.438.43001 Boehringer Ingelheim Investigational Site
City
Innsbruck
Country
Austria
Facility Name
205.438.43002 Boehringer Ingelheim Investigational Site
City
Salzburg
Country
Austria
Facility Name
205.438.32002 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
205.438.32004 Boehringer Ingelheim Investigational Site
City
Edegem
Country
Belgium
Facility Name
205.438.32003 Boehringer Ingelheim Investigational Site
City
Jette
Country
Belgium
Facility Name
205.438.32001 Boehringer Ingelheim Investigational Site
City
Leuven
Country
Belgium
Facility Name
205.438.02005 Boehringer Ingelheim Investigational Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
205.438.02007 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
205.438.02004 Boehringer Ingelheim Investigational Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
205.438.02003 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
205.438.02006 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
205.438.02001 Boehringer Ingelheim Investigational Site
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
205.438.42002 Boehringer Ingelheim Investigational Site
City
Brno
Country
Czech Republic
Facility Name
205.438.42003 Boehringer Ingelheim Investigational Site
City
Brno
Country
Czech Republic
Facility Name
205.438.42004 Boehringer Ingelheim Investigational Site
City
Olomouc
Country
Czech Republic
Facility Name
205.438.42001 Boehringer Ingelheim Investigational Site
City
Prague 5
Country
Czech Republic
Facility Name
205.438.33010 Boehringer Ingelheim Investigational Site
City
Angers
Country
France
Facility Name
205.438.33013 Boehringer Ingelheim Investigational Site
City
BRON Cedex
Country
France
Facility Name
205.438.33002 Boehringer Ingelheim Investigational Site
City
Lille Cedex
Country
France
Facility Name
205.438.33015 Boehringer Ingelheim Investigational Site
City
Lisieux
Country
France
Facility Name
205.438.33003 Boehringer Ingelheim Investigational Site
City
Montpellier
Country
France
Facility Name
205.438.33005 Boehringer Ingelheim Investigational Site
City
Nantes
Country
France
Facility Name
205.438.33014 Boehringer Ingelheim Investigational Site
City
Nice Cedex 1
Country
France
Facility Name
205.438.33001 Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
205.438.33006 Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
205.438.33007 Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
205.438.33011 Boehringer Ingelheim Investigational Site
City
Rennes
Country
France
Facility Name
205.438.33008 Boehringer Ingelheim Investigational Site
City
Roscoff Cedex
Country
France
Facility Name
205.438.33004 Boehringer Ingelheim Investigational Site
City
Rouen cedex
Country
France
Facility Name
205.438.33009 Boehringer Ingelheim Investigational Site
City
Vannes
Country
France
Facility Name
205.438.49001 Boehringer Ingelheim Investigational Site
City
Bochum
Country
Germany
Facility Name
205.438.49011 Boehringer Ingelheim Investigational Site
City
Frankfurt/Main
Country
Germany
Facility Name
205.438.49002 Boehringer Ingelheim Investigational Site
City
Frankfurt
Country
Germany
Facility Name
205.438.49012 Boehringer Ingelheim Investigational Site
City
Frankfurt
Country
Germany
Facility Name
205.438.49006 Boehringer Ingelheim Investigational Site
City
Gerlingen
Country
Germany
Facility Name
205.438.49007 Boehringer Ingelheim Investigational Site
City
Gießen
Country
Germany
Facility Name
205.438.49005 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
205.438.49003 Boehringer Ingelheim Investigational Site
City
München
Country
Germany
Facility Name
205.438.49008 Boehringer Ingelheim Investigational Site
City
Tübingen
Country
Germany
Facility Name
205.438.36002 Boehringer Ingelheim Investigational Site
City
Budapest
Country
Hungary
Facility Name
205.438.36003 Boehringer Ingelheim Investigational Site
City
Mosdos
Country
Hungary
Facility Name
205.438.36004 Boehringer Ingelheim Investigational Site
City
Szeged
Country
Hungary
Facility Name
205.438.35301 Boehringer Ingelheim Investigational Site
City
Dublin 12
Country
Ireland
Facility Name
205.438.97003 Boehringer Ingelheim Investigational Site
City
Haifa
Country
Israel
Facility Name
205.438.97001 Boehringer Ingelheim Investigational Site
City
Jerusalem
Country
Israel
Facility Name
205.438.97002 Boehringer Ingelheim Investigational Site
City
Petach Tikva
Country
Israel
Facility Name
205.438.97004 Boehringer Ingelheim Investigational Site
City
Tel Hashomer
Country
Israel
Facility Name
205.438.39001 Boehringer Ingelheim Investigational Site
City
Firenze
Country
Italy
Facility Name
205.438.39003 Boehringer Ingelheim Investigational Site
City
Genova
Country
Italy
Facility Name
205.438.39002 Boehringer Ingelheim Investigational Site
City
Verona
Country
Italy
Facility Name
205.438.48001 Boehringer Ingelheim Investigational Site
City
Lodz
Country
Poland
Facility Name
205.438.48002 Boehringer Ingelheim Investigational Site
City
Rabka Zdroj
Country
Poland
Facility Name
205.438.48003 Boehringer Ingelheim Investigational Site
City
Warszawa
Country
Poland
Facility Name
205.438.35001 Boehringer Ingelheim Investigational Site
City
Lisboa
Country
Portugal
Facility Name
205.438.35002 Boehringer Ingelheim Investigational Site
City
Lisboa
Country
Portugal
Facility Name
205.438.35003 Boehringer Ingelheim Investigational Site
City
Porto
Country
Portugal
Facility Name
205.438.35004 Boehringer Ingelheim Investigational Site
City
Porto
Country
Portugal
Facility Name
205.438.07001 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
205.438.07005 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
205.438.07003 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
205.438.07004 Boehringer Ingelheim Investigational Site
City
Voronezh
Country
Russian Federation
Facility Name
205.438.07002 Boehringer Ingelheim Investigational Site
City
Yaroslavl
Country
Russian Federation
Facility Name
205.438.42102 Boehringer Ingelheim Investigational Site
City
Banska Bystrica
Country
Slovakia
Facility Name
205.438.42101 Boehringer Ingelheim Investigational Site
City
Bratislava
Country
Slovakia
Facility Name
205.438.42103 Boehringer Ingelheim Investigational Site
City
Kosice
Country
Slovakia
Facility Name
205.438.27001 Boehringer Ingelheim Investigational Site
City
Cape Town
Country
South Africa
Facility Name
205.438.34005 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
205.438.34001 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
205.438.34002 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
205.438.34004 Boehringer Ingelheim Investigational Site
City
Valencia
Country
Spain
Facility Name
205.438.41003 Boehringer Ingelheim Investigational Site
City
Basel
Country
Switzerland
Facility Name
205.438.41004 Boehringer Ingelheim Investigational Site
City
Bern 4
Country
Switzerland
Facility Name
205.438.41001 Boehringer Ingelheim Investigational Site
City
Zürich
Country
Switzerland
Facility Name
205.438.41002 Boehringer Ingelheim Investigational Site
City
Zürich
Country
Switzerland
Facility Name
205.438.44009 Boehringer Ingelheim Investigational Site
City
Brighton
Country
United Kingdom
Facility Name
205.438.44007 Boehringer Ingelheim Investigational Site
City
Cambridge
Country
United Kingdom
Facility Name
205.438.44004 Boehringer Ingelheim Investigational Site
City
Leeds
Country
United Kingdom
Facility Name
205.438.44005 Boehringer Ingelheim Investigational Site
City
Nottingham
Country
United Kingdom
Facility Name
205.438.44002 Boehringer Ingelheim Investigational Site
City
Plymouth
Country
United Kingdom
Facility Name
205.438.44003 Boehringer Ingelheim Investigational Site
City
Sheffield
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
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.438_U12-1163-01-DS.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.438_Literature.pdf
Description
Related Info

Learn more about this trial

Tiotropium Bromide in Cystic Fibrosis

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