The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 MDI compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
PT005 MDI taken as two inhalations
Taken as 1 capsule. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
Taken as 2 capsules. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
Pearl Investigative Site
Clearwater, Florida, United States
Pearl Investigative Site
Tampa, Florida, United States
Pearl Investigative Site
Spartanburg, South Carolina, United States
Change in FEV1 AUC0-12 from test day baseline across the three doses of inhaled PT005 compared with placebo
The primary objective of this study is to demonstrate efficacy relative to placebo of PT005 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this study. To this end, each dose of PT005 MDI will be compared to placebo with respect to the primary efficacy endpoint, the change in FEV1 AUC0-12 from baseline.
Time frame: 1 Day
Characterize the dose-response curve of PT005 MDI
The secondary objective of the study is to characterize the dose-response curve of PT005 MDI, to conduct a non-inferiority assessment comparing PT005 MDI within the range of doses evaluated in this study to open-label Foradil Aerolizer 12 µg, and to select the most appropriate dose of PT005 MDI to carry forward into Phase III clinical studies
Time frame: 1 Day
Safety measures including electrocardiograms (ECGs), vital signs, physical exam, clinical laboratory testing, and adverse events
Time frame: 1 Day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Matching placebo to PT005 MDI taken as two inhalations