The purpose of this study is to evaluate the safety and efficacy of inhaled PT001 compared to placebo and tiotropium in patients with mild to moderate chronic obstructive pulmonary disease (COPD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
single dose, inhaled
single dose, inhaled
single dose, tiotropium 18 mcg administered via the Handihaler
Pivotal Research Centers
Peoria, Arizona, United States
National Jewish Health
Denver, Colorado, United States
Elite Research Institute
Miami, Florida, United States
Pulmonary and Critical Care Medicine
Omaha, Nebraska, United States
Peak improvement in forced expiratory volume in one second (FEV1)
Day 1 serial FEV1 measured over 24 hours
Time frame: Day 1
Time to onset of action (>10% improvement in FEV1 from baseline)
Day 1 serial FEV1 measured over 24 hours
Time frame: Day 1
Time to peak FEV1
Day 1 serial FEV1 measured over 24 hours
Time frame: Day 1
FEV1 area under the curve (AUC) from 0 to 24 hours
Day 1 serial FEV1 measured over 24 hours
Time frame: Day 1
FEV1 AUC from 0 to 12 hours
Day 1 serial FEV1 measured over 24 hours
Time frame: Day 1
Trough FEV1 at 12 and 24 hours
Day 1 serial FEV1 measured over 24 hours
Time frame: Day 1
Peak Improvement in inspiratory capacity (IC)
Day 1 serial IC measured over 24 hours
Time frame: Day 1
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Cincinnati VAMC
Cincinnati, Ohio, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States