The primary objective of the study is to characterize the safety profile and duration of bronchodilation of a single dose of inhaled TV48108.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
61
Teva Investigational Site 13038
Medford, Oregon, United States
Teva Investigational Site 13039
Spartanburg, South Carolina, United States
Teva Investigational Site 78992
Clayton, Australia
Teva Investigational Site 78993
Daws Park, Australia
Baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours (FEV1 AUC0-12h).
Time frame: Day 1 (pre-dose, up to 12 hours post-dose)
Baseline Adjusted Trough 12 hour forced expiratory volume in 1 second (FEV1)
Time frame: Day 1 (pre-dose, up to 12 hours post-dose)
Percentage of Participants with Adverse Events
Time frame: 28 Days
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Teva Investigational Site 78991
Melbourne, Australia
Teva Investigational Site 79041
Auckland, New Zealand
Teva Investigational Site 79040
Christchurch, New Zealand