The purpose of this study is to evaluate the safety and efficacy of inhaled formoterol fumarate (7.2 and 9.6 µg ex-actuator) compared to placebo and Foradil Aerolizer in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
inhaled, twice daily for 1 week duration
inhaled, twice daily for 1 week duration
inhaled, twice daily for 1 week duration
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Change in forced expiratory volume in one second (FEV1) area under the curve from 0 to 12 hours [AUC(0-12)] from test day baseline across the two doses of inhaled PT005 compared with placebo.
Time frame: Day 7
Lung Function Measures on Day 7 as measured by spirometry.
Time frame: Day 7
Safety measures including electrocardiograms (ECGs), vital signs, physical exam, clinical laboratory testing, and adverse events of special interest
Time frame: Day 7
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