Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis
- Conditions
- Cystic Fibrosis
- Interventions
- Registration Number
- NCT00737100
- Lead Sponsor
- Boehringer Ingelheim
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 510
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Respimat Placebo Respimat patient to receive placebo once daily Tiotropium Respimat 2.5 mcg tiotropium bromide-low dose-2.5mcg patient to receive low dose tiotropium once daily Tiotropium Respimat 5 mcg Tiotropium bromide 5 mcg patient to receive high dose tiotropium once daily
- Primary Outcome Measures
Name Time Method Percent Predicted FEV1 AUC0-4 Response at the End of Week 12 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.
Percent Predicted FEV1 Trough Response at the End of Week 12 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.
- Secondary Outcome Measures
Name Time Method Respiratory and Systemic Symptoms Questionnaire (RSSQ) 12 weeks Outcome measure description: The RSSQ questionnaire is used to determine the presence or absence of an exacerbation during the recall period.
Percent Predicted FVC AUC0-4 Response at the End of Week 12 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.
Percent Predicted FVC Trough Response at the End of Week 12 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.
Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12 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.
Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12 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.
Change From Baseline in CFQ Scores - Adult Group 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.
Change From Baseline in CFQ Scores - Adolescents Group 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.
Change From Baseline in CFQ Scores - Parent Questionnaire 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.
Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss) 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
Maximum Measured Concentration at Steady State (Cmax,ss) 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.
Time From Dosing to the Maximum Concentration (Tmax,ss) 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
Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation 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.
Trial Locations
- Locations (107)
205.339.021 Boehringer Ingelheim Investigational Site
🇺🇸Miami, Florida, United States
205.339.024 Boehringer Ingelheim Investigational Site
🇺🇸Cleveland, Ohio, United States
205.339.022 Boehringer Ingelheim Investigational Site
🇺🇸Indianapolis, Indiana, United States
205.339.026 Boehringer Ingelheim Investigational Site
🇺🇸Colchester, Vermont, United States
205.339.104 Boehringer Ingelheim Investigational Site
🇦🇺Subiaco, Western Australia, Australia
205.339.3317A Boehringer Ingelheim Investigational Site
🇫🇷Angers, France
205.339.010 Boehringer Ingelheim Investigational Site
🇺🇸Charleston, South Carolina, United States
205.339.030 Boehringer Ingelheim Investigational Site
🇺🇸Orlando, Florida, United States
205.339.017 Boehringer Ingelheim Investigational Site
🇺🇸Ann Arbor, Michigan, United States
205.339.110 Boehringer Ingelheim Investigational Site
🇧🇪Leuven, Belgium
205.339.3314B Boehringer Ingelheim Investigational Site
🇫🇷BRON Cedex, France
205.339.3302C Boehringer Ingelheim Investigational Site
🇫🇷Lille Cedex, France
205.339.3303A Boehringer Ingelheim Investigational Site
🇫🇷Lisieux, France
205.339.3308B Boehringer Ingelheim Investigational Site
🇫🇷Nantes, France
205.339.3318C Boehringer Ingelheim Investigational Site
🇫🇷Rennes, France
205.339.3302A Boehringer Ingelheim Investigational Site
🇫🇷Lille Cedex, France
205.339.3315D Boehringer Ingelheim Investigational Site
🇫🇷Roscoff Cedex, France
205.339.49137 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt, Germany
205.339.49140 Boehringer Ingelheim Investigational Site
🇩🇪München, Germany
205.339.233 Boehringer Ingelheim Investigational Site
🇮🇹Ancona, Italy
205.339.07007 Boehringer Ingelheim Investigational Site
🇷🇺Rostov-on-Don, Russian Federation
205.339.031 Boehringer Ingelheim Investigational Site
🇺🇸Orlando, Florida, United States
205.339.07001 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
205.339.07002 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
205.339.3317C Boehringer Ingelheim Investigational Site
🇫🇷Angers, France
205.339.3301B Boehringer Ingelheim Investigational Site
🇫🇷Paris Cedex 14, France
205.339.49132 Boehringer Ingelheim Investigational Site
🇩🇪Erlangen, Germany
205.339.49133 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt/Main, Germany
205.339.106 Boehringer Ingelheim Investigational Site
🇳🇿Hamilton, New Zealand
205.339.221 Boehringer Ingelheim Investigational Site
🇵🇹Lisboa, Portugal
205.339.07005 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
205.339.07004 Boehringer Ingelheim Investigational Site
🇷🇺Yaroslavl, Russian Federation
205.339.018 Boehringer Ingelheim Investigational Site
🇺🇸Lebanon, New Hampshire, United States
205.339.07003 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
205.339.3315C Boehringer Ingelheim Investigational Site
🇫🇷Roscoff Cedex, France
205.339.3306B Boehringer Ingelheim Investigational Site
🇫🇷Rouen cedex, France
205.339.3316A Boehringer Ingelheim Investigational Site
🇫🇷Vannes, France
205.339.49134 Boehringer Ingelheim Investigational Site
🇩🇪Freiburg, Germany
205.339.49142 Boehringer Ingelheim Investigational Site
🇩🇪München, Germany
205.339.171 Boehringer Ingelheim Investigational Site
🇳🇱Groesbeek, Netherlands
205.339.170 Boehringer Ingelheim Investigational Site
🇳🇱Rotterdam, Netherlands
205.339.105 Boehringer Ingelheim Investigational Site
🇳🇿Grafton / Auckland, New Zealand
205.339.225 Boehringer Ingelheim Investigational Site
🇵🇹Lisboa, Portugal
205.339.223 Boehringer Ingelheim Investigational Site
🇵🇹Porto, Portugal
205.339.07006 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
205.339.029 Boehringer Ingelheim Investigational Site
🇺🇸Long Branch, New Jersey, United States
205.339.009 Boehringer Ingelheim Investigational Site
🇺🇸Morristown, New Jersey, United States
205.339.3312C Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
205.339.3313A Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
205.339.3308A Boehringer Ingelheim Investigational Site
🇫🇷Nantes, France
205.339.3308C Boehringer Ingelheim Investigational Site
🇫🇷Nantes, France
205.339.3307A Boehringer Ingelheim Investigational Site
🇫🇷Rouen cedex, France
205.339.49130 Boehringer Ingelheim Investigational Site
🇩🇪Tübingen, Germany
205.339.224 Boehringer Ingelheim Investigational Site
🇵🇹Porto, Portugal
205.339.07008 Boehringer Ingelheim Investigational Site
🇷🇺Voronezh, Russian Federation
205.339.49145 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
205.339.3306A Boehringer Ingelheim Investigational Site
🇫🇷Rouen cedex, France
205.339.3309A Boehringer Ingelheim Investigational Site
🇫🇷Vandoeuvre les Nancy, France
205.339.49141 Boehringer Ingelheim Investigational Site
🇩🇪Heidelberg, Germany
205.339.005 Boehringer Ingelheim Investigational Site
🇺🇸Salt Lake City, Utah, United States
205.339.020 Boehringer Ingelheim Investigational Site
🇺🇸Oklahoma City, Oklahoma, United States
205.339.032 Boehringer Ingelheim Investigational Site
🇺🇸Oklahoma City, Oklahoma, United States
205.339.003 Boehringer Ingelheim Investigational Site
🇺🇸Milwaukee, Wisconsin, United States
205.339.001 Boehringer Ingelheim Investigational Site
🇺🇸Iowa City, Iowa, United States
205.339.004 Boehringer Ingelheim Investigational Site
🇺🇸Fort Worth, Texas, United States
205.339.006 Boehringer Ingelheim Investigational Site
🇺🇸Tucson, Arizona, United States
205.339.014 Boehringer Ingelheim Investigational Site
🇺🇸Indianapolis, Indiana, United States
205.339.002 Boehringer Ingelheim Investigational Site
🇺🇸Syracuse, New York, United States
205.339.49135 Boehringer Ingelheim Investigational Site
🇩🇪Hannover, Germany
205.339.231 Boehringer Ingelheim Investigational Site
🇮🇹Firenze, Italy
205.339.3312A Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
205.339.3318G Boehringer Ingelheim Investigational Site
🇫🇷Rennes, France
205.339.44194 Boehringer Ingelheim Investigational Site
🇬🇧Plymouth, United Kingdom
205.339.44181 Boehringer Ingelheim Investigational Site
🇬🇧Sheffield, United Kingdom
205.339.44193 Boehringer Ingelheim Investigational Site
🇬🇧Boston, United Kingdom
205.339.44185 Boehringer Ingelheim Investigational Site
🇬🇧Liverpool, United Kingdom
205.339.44184 Boehringer Ingelheim Investigational Site
🇬🇧Wolverhampton, United Kingdom
205.339.44190 Boehringer Ingelheim Investigational Site
🇬🇧Birmingham, United Kingdom
205.339.44186 Boehringer Ingelheim Investigational Site
🇬🇧Liverpool, United Kingdom
205.339.44183 Boehringer Ingelheim Investigational Site
🇬🇧Nottingham, United Kingdom
205.339.44182 Boehringer Ingelheim Investigational Site
🇬🇧Oxford, United Kingdom
205.339.023 Boehringer Ingelheim Investigational Site
🇺🇸Jacksonville, Florida, United States
205.339.019 Boehringer Ingelheim Investigational Site
🇺🇸San Diego, California, United States
205.339.013 Boehringer Ingelheim Investigational Site
🇺🇸South Bend, Indiana, United States
205.339.016 Boehringer Ingelheim Investigational Site
🇺🇸Grand Rapids, Michigan, United States
205.339.025 Boehringer Ingelheim Investigational Site
🇺🇸Detroit, Michigan, United States
205.339.011 Boehringer Ingelheim Investigational Site
🇺🇸Charlottesville, Virginia, United States
205.339.101 Boehringer Ingelheim Investigational Site
🇦🇺Westmead, New South Wales, Australia
205.339.111 Boehringer Ingelheim Investigational Site
🇧🇪Bruxelles, Belgium
205.339.100 Boehringer Ingelheim Investigational Site
🇦🇺Westmead, New South Wales, Australia
205.339.112 Boehringer Ingelheim Investigational Site
🇧🇪Jette, Belgium
205.339.3310A Boehringer Ingelheim Investigational Site
🇫🇷Amiens, France
205.339.3317D Boehringer Ingelheim Investigational Site
🇫🇷Angers, France
205.339.3317E Boehringer Ingelheim Investigational Site
🇫🇷Angers, France
205.339.3314A Boehringer Ingelheim Investigational Site
🇫🇷BRON Cedex, France
205.339.3314C Boehringer Ingelheim Investigational Site
🇫🇷BRON Cedex, France
205.339.3302B Boehringer Ingelheim Investigational Site
🇫🇷Lille, France
205.339.3304A Boehringer Ingelheim Investigational Site
🇫🇷Montpellier, France
205.339.3304B Boehringer Ingelheim Investigational Site
🇫🇷Montpellier, France
205.339.3318A Boehringer Ingelheim Investigational Site
🇫🇷Rennes, France
205.339.49131 Boehringer Ingelheim Investigational Site
🇩🇪Gerlingen, Germany
205.339.234 Boehringer Ingelheim Investigational Site
🇮🇹Genova, Italy
205.339.44180 Boehringer Ingelheim Investigational Site
🇬🇧Belfast, United Kingdom
205.339.44192 Boehringer Ingelheim Investigational Site
🇬🇧Leeds, United Kingdom
205.339.44191 Boehringer Ingelheim Investigational Site
🇬🇧Lincoln, United Kingdom
205.339.103 Boehringer Ingelheim Investigational Site
🇦🇺Adelaide, South Australia, Australia
205.339.3313B Boehringer Ingelheim Investigational Site
🇫🇷Paris, France