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 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.
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.
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)
205.339.006 Boehringer Ingelheim Investigational Site
🇺🇸Tucson, Arizona, United States
205.339.019 Boehringer Ingelheim Investigational Site
🇺🇸San Diego, California, United States
205.339.023 Boehringer Ingelheim Investigational Site
🇺🇸Jacksonville, Florida, United States
205.339.021 Boehringer Ingelheim Investigational Site
🇺🇸Miami, Florida, United States
205.339.030 Boehringer Ingelheim Investigational Site
🇺🇸Orlando, Florida, United States
205.339.031 Boehringer Ingelheim Investigational Site
🇺🇸Orlando, Florida, United States
205.339.014 Boehringer Ingelheim Investigational Site
🇺🇸Indianapolis, Indiana, United States
205.339.022 Boehringer Ingelheim Investigational Site
🇺🇸Indianapolis, Indiana, United States
205.339.013 Boehringer Ingelheim Investigational Site
🇺🇸South Bend, Indiana, United States
205.339.001 Boehringer Ingelheim Investigational Site
🇺🇸Iowa City, Iowa, United States
Scroll for more (97 remaining)205.339.006 Boehringer Ingelheim Investigational Site🇺🇸Tucson, Arizona, United States