Main study: To investigate safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of BEA 2180 BR Sub-study; To investigate whether treatment with 36 μg tiotropium bromide is able to protect of methacholine-induced bronchoconstriction compared to baseline (methacholine challenge at screening).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
101
Number of subjects with clinically significant changes in vital signs
blood pressure, pulse rate, respiratory rate, oral body temperature
Time frame: up to 14 days after last drug administration
Number of subjects with clinically significant changes in laboratory parameters
Time frame: up to 14 days after last drug administration
Changes from baseline in airway resistance (Raw)
assessed by body plethysmography
Time frame: up to 120 hours after drug administration
Changes from baseline in specific airway conductance (sGaw)
assessed by body plethysmography
Time frame: up to 120 hours after drug administration
Number of subjects with clinically significant findings in 12-lead ECG (electrocardiogram)
Time frame: up to 14 days after last drug administration
Number of subjects with adverse events
Time frame: up to 14 days after last drug administration
Assessment of tolerability by investigator on a 5-point scale
Time frame: within 14 days after last drug administration
Changes from baseline in salivary secretion
Time frame: up to 24 hours after drug administration
Changes from baseline in pupil diameter of each eye
pupillometry
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Time frame: up to 4 hours after drug administration
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to 240 hours after drug administration
Measured concentration of the analyte in plasma (C) for several time points
Time frame: up to 24 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time frame: up to 240 hours after drug administration
Amount of parent drug that is eliminated in urine (Ae)
Time frame: up to 312 hours after drug administration
Fraction of administered drug excreted unchanged in urine (fe)
Time frame: up to 312 hours after drug administration
Area under the concentration-time curve of the analyte in plasma (AUC)
Time frame: up to 240 hours after drug administration
Renal clearance of the analyte (CLR)
Time frame: up to 312 hours after drug administration
Terminal rate constant of the analyte in plasma (λZ)
Time frame: up to 240 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Time frame: up to 240 hours after drug administration
Mean residence time of the analyte in the body after inhaled administration (MRTinh)
Time frame: up to 240 hours after drug administration
Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
Time frame: up to 240 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an extravascular dose (VZ/F)
Time frame: up to 240 hours after drug administration