Study to investigate the dose-dependent bronchodilator effect and the safety of single inhalation doses of BEA 2180 inhaled via Respimat® compared to placebo in patients with stable Chronic Obstructive Pulmonary Disease (COPD)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
37
Change in Mean Forced Expiratory Volume in 1st second (FEV1)
Time frame: 23 and 24 hours after single inhalation
Change in FEV1 Area under the concentration-time curve over the respective time interval (AUCtime-interval)
Time frame: predose, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 23, 24, 26 and 28 hours after inhalation of each single dose
Peak FEV1
Time frame: within 3 hours after inhalation of each single dose
Time to peak bronchodilatory response
Time frame: within 3 hours after inhalation of each single dose
Change in Forced Vital Capacity (FVC) AUCtime-interval
Time frame: predose, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 23, 24, 26 and 28 hours after inhalation of each single dose
Change in individual FEV1 measurements
Time frame: up to 71 days
Change in individual FVC measurements
Time frame: up to 71 days
Number of patients with adverse events
Time frame: up to 85 days
Area under the plasma concentration-time curve over the respective time interval (AUCtime-interval)
Time frame: predose, 5 min, 30min, 2 h, 8 h , 24 h
Pre-dose plasma concentration immediately before the inhalation of each single dose (Cpre)
Time frame: predose
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Maximum measured plasma concentration following the inhalation of each single dose (Cmax)
Time frame: predose, 5 min, 30min, 2 h, 8 h , 24 h
Time from dosing to the maximum plasma concentration the inhalation of each single dose of randomised treatment (tmax)
Time frame: predose, 5 min, 30min, 2 h, 8 h , 24 h
Amount of unchanged drug excreted over the respective time intervals (Aetime-interval)
Time frame: predose, 0-4 h, 4-24 h
Renal clearance of the analyte from the time point t1 until the time point t2 (CLR,t1-t2)
Time frame: predose, 0-4 h, 4-24 h
Fraction of analyte eliminated in urine from different time intervals (fetime-interval)
Time frame: predose, 0-4 h, 4-24 h
Peak FVC
Time frame: within 3 hours after inhalation of each single dose