The purpose of this study is compare the effect of different doses of tiotropium delivered by the HandiHaler and Respimat device on lung function. Additionally, the study will investigate the pharmacokinetic profile of these different doses. Studying the pharmacokinetic profile shows what happens to the medication in the body over a period of hours and provides information on potential effects of the medication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
154
Tiotropium inhalation solution medium dose
Tiotropium inhalation solution low dose
Tiotropium inhalation solution high dose
205.458.32003 Boehringer Ingelheim Investigational Site
Genk, Belgium
205.458.32001 Boehringer Ingelheim Investigational Site
Ghent, Belgium
205.458.32002 Boehringer Ingelheim Investigational Site
Hasselt, Belgium
Maximum Plasma Concentration at Steady-state (Cmax,ss)
Cmax,ss is the maximum measured concentration of tiotropium in plasma at steady-state.
Time frame: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.
Area Under the Curve 0 to 6 Hours at Steady-state (AUC0-6h,ss)
AUC0-6h,ss is the area under the concentration time curve of tiotropium in plasma over the time interval 0 to 6 hours post-dose at steady-state. AUC0-6h,ss was calculated using the linear up/log down algorithm.
Time frame: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.
Trough Forced Expiratory Volume in One Second (FEV1) at the End of Each Treatment Period
Defined as FEV1 measured just prior to the last administration of the morning dose of the randomised treatment. Means are adjusted for sequence, patients within sequences, period and treatment.
Time frame: 4 weeks
FEV1 Area Under the Curve 0 to 6 Hours (AUC0-6h) at the End of Each Treatment Period
FEV1 AUC0-6h calculated from zero time to 6 hours using the trapezoidal rule divided by 6 hours. Trough FEV1 will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.
Time frame: 4 weeks
FEV1 Area Under the Curve 0 to 3 Hours (AUC0-3h) at the End of Each Treatment Period
FEV1 AUC0-3h calculated from zero time to 3 hours using the trapezoidal rule divided by 3 hours. Trough FEV1 will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.
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Tiotropium inhalation powder 18mcg
Placebo inhalation solution
205.458.45001 Boehringer Ingelheim Investigational Site
Copenhagen K, Denmark
205.458.45003 Boehringer Ingelheim Investigational Site
København NV, Denmark
205.458.45002 Boehringer Ingelheim Investigational Site
Odense C, Denmark
205.458.35801 Boehringer Ingelheim Investigational Site
Helsinki, Finland
205.458.35802 Boehringer Ingelheim Investigational Site
Tampere, Finland
205.458.49001 Boehringer Ingelheim Investigational Site
Hanover, Germany
205.458.31001 Atrium Medisch Centrum Parkstad
Heerlen, Netherlands
...and 1 more locations
Time frame: 4 weeks
Trough Forced Vital Capacity (FVC) at the End of Each Treatment Period
Defined as the pre-dose FVC measured just prior to the last administration of the morning dose of the randomised treatment. Means are adjusted for sequence, patients within sequences, period and treatment.
Time frame: 4 weeks
FVC AUC0-6h at the End of Each Treatment Period
FVC AUC0-6h calculated from zero time to 6 hours using the trapezoidal rule divided by 6 hours. Trough FVC will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.
Time frame: 4 weeks
FVC AUC0-3h at the End of Each Treatment Period
FVC AUC0-3h calculated from zero time to 3 hours using the trapezoidal rule divided by 3 hours. Trough FVC will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.
Time frame: 4 weeks
FEV1 at Each Planned Time at the End of Each Treatment Period
Means are adjusted for period, planned time, period\*planned time, patient\*planned time and patient\*treatment\*planned time.
Time frame: 4 weeks
FVC at Each Planned Time at the End of Each Treatment Period
Means are adjusted for period, planned time, period\*planned time, patient\*planned time and patient\*treatment\*planned time.
Time frame: 4 weeks
Area Under the Curve 0 to 1 Hour at Steady-state (AUC0-1h,ss)
AUC0-1h,ss is the area under the concentration time curve of tiotropium in plasma over the time interval 0 to 1 hour post-dose at steady-state. AUC0-1h,ss was calculated using the linear up/log down algorithm.
Time frame: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.
Time to Maximum Plasma Concentration at Steady-state (Tmax,ss)
Tmax,ss is the time from dosing to the maximum concentration of tiotropium in plasma-venous blood at steady-state.
Time frame: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 min before first dosing of study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 h, 2 h, 4 h and 6 h post dosing.
Amount of Drug Eliminated in Urine at Steady-state (Ae0-6h,ss)
Total quantity of the analyte that is excreted in urine over the time interval 0 to 6 hours at steady state.
Time frame: Based on urine sampling for PK assessments done at 4 weeks in the following intervals: -1 to 0 hour (h), 0 to 2 h and 2 to 6 h post-dosing.
Pre-dose Plasma Concentration at Steady-state (Cpre,ss)
Cpre,ss is the measured concentration of tiotropium in plasma before dosing at steady-state.
Time frame: Based on blood sampling for PK assessments done at 4 weeks at the following time point: 5 minutes (min) before first dosing of study drug (baseline)
Renal Clearance at Steady-state (CL R,0-6h,ss)
Renal clearance of the drug over the time interval 0 to 6 hours at steady-state. CL R,0-6h,ss was calculated as the quotient of Ae0-6h,ss and AUC0-6h,ss.
Time frame: Based on blood and urine sampling for PK assessments done at 4 weeks over 6 h post dosing.
Minimum Plasma Concentration at Steady-state (Cmin,ss)
Cmin,ss is the minimum measured concentration of tiotropium in plasma at steady-state.
Time frame: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 min before first dosing of study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 h, 2 h, 4 h and 6 h post dosing.