To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
47
Number of patients with clinically significant changes in physical examination
Time frame: Baseline, day 32 (end-of-study examination)
Number of patients with clinically significant changes in vital signs
Time frame: Baseline, up to day 32
Number of patients with clinically significant changes in 12-lead ECG (Electrocardiogram)
Time frame: Baseline, up to day 32
Number of patients with abnormal changes in laboratory tests
Time frame: Baseline, up to day 32
Changes in airway resistance (Raw) measured by body plethysmography
Time frame: Baseline, up to day 32
Changes in tremormetry parameters
Time frame: Baseline, up to day 32
Number of patients with adverse events
Time frame: Up to day 32
Assessment of tolerability by the investigator on a 4-point scale
Time frame: Day 32 (end-of-study examination)
Cmax (maximum concentration of the analyte in plasma)
Time frame: Up to 408 hours after drug administration
tmax (time from dosing to maximum concentration)
Time frame: Up to 408 hours after drug administration
AUC (area under the concentration-time curve of the analyte in plasma at different time points)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 408 hours after drug administration
Aet1-t2(amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Time frame: Up to 384 hours after drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: Up to 384 hours after drug administration
%AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation)
Time frame: Up to 408 hours after drug administration
λz (terminal rate constant of the analyte in plasma)
Time frame: Up to 408 hours after drug administration
t½ (terminal half-life of the analyte in plasma)
Time frame: Up to 408 hours after drug administration
MRTih (mean residence time of the analyte in the body after inhalation)
Time frame: Up to 408 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: Up to 408 hours after drug administration
Vz/F (apparent volume of distribution of the analyte during the terminal phase λz following an extravascular dose)
Time frame: Up to 408 hours after drug administration
CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 until the time point t2)
Time frame: Up to 408 hours after drug administration
RA,Cmax,14 based on Cmax (Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ)
Time frame: Up to 408 hours after drug administration
RA,AUC,14 based on AUC0-τ
Time frame: Up to 408 hours after drug administration
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Up to 408 hours after drug administration
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Time frame: Up to 408 hours after drug administration
Linearity Index (LI)
Time frame: Up to 408 hours after drug administration