To investigate the dose response following single inhalation of Ba 679 BR inhalation powder in COPD patients using pulmonary functions as indicators, and to compare data obtained with overseas study findings
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
FEV1.0 max (maximum forced expiratory volume in one second)
Time frame: before and up to 24 hours after each study drug administration
FEV1.0 AUC 0-24 (forced expiratory volume in one second as area under the curve 0 to 24 hours after administration)
Time frame: before and up to 24 hours after each study drug administration
FEV1.0 time to response
Time frame: before and up to 24 hours after each study drug administration
FEV1.0 Tmax (time to FEV1.0 max)
Time frame: before and up to 24 hours after each study drug administration
FEV1.0 at measuring time points up to 24 hours after administration of study drug
Time frame: before and up to 24 hours after each study drug administration
FVC AUC 0-24 (forced vital capacity as area under the curve 0 to 24 hours after administration)
Time frame: before and up to 24 hours after each study drug administration
FVC max
Time frame: before and up to 24 hours after each study drug administration
FVC at measuring time points up to 24 hours after administration of study drug
Time frame: before and up to 24 hours after each study drug administration
Occurrence of adverse events
Time frame: up to 29 days
Changes in blood pressure
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Time frame: before and up to 24 hours after each study drug administration
Changes in pulse rate
Time frame: before and up to 24 hours after each study drug administration
Changes in transdermal O2 saturation
Time frame: before and up to 24 hours after each study drug administration
Abnormal findings in electrocardiogram (ECG)
Time frame: before and 1.5 and 24 hours after each administration of study drug
Abnormal changes in laboratory measurements
Time frame: at 24 hours after last study drug administration
Urinary excretion rate
Time frame: before (from 4 hours pre-dosing until immediately before dosing) and 0-2, 2-4, 4-8, 8-12 and 12-24 hours after drug administration
MMEF AUC 0-24 (maximal midexpiratory flow as area under the curve 0 to 24 hours after administration)
Time frame: before and up to 24 hours after each study drug administration
MMEF max
Time frame: before and up to 24 hours after each study drug administration
MMEF at measuring time points up to 24 hours after administration of study drug
Time frame: before and up to 24 hours after each study drug administration