The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.
The primary objective of this study is to demonstrate efficacy relative to placebo of PT001 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of PT001 MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
103
PT001 MDI administered as two puffs BID for 7 days
Taken as 2 inhalations of the 17 µg per actuation strength MDI QID
Matching placebo to PT001 MDI administered as two puffs BID for 7 days
Pearl Investigative Site
Panama City, Florida, United States
Pearl Investigative Site
Winter Park, Florida, United States
Pearl Investigative Site
Cherry Hill, New Jersey, United States
Pearl Investigative Site
Summit, New Jersey, United States
FEV1 AUC0-12
FEV1 AUC0-12 following chronic dosing (1 week), normalized.
Time frame: Day 7 ( -1 hour, -30 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5.5 hours, 6.5 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours)
Peak Change From Baseline in FEV1 on Day 1
Highest value of FEV1 post-dose minus baseline on Day 1 (baseline-adjusted)
Time frame: Day 1
Time to Onset of Action ( ≥10% Improvement in FEV1) on Day 1
Time to onset of action ( ≥10% improvement in FEV1)
Time frame: Day 1 (15 min, 30 min, 1 hour, 2 hours)
Proportion of Subjects Achieving at Least 12% Improvement in FEV1 on Day 1
Proportion of subjects achieving at least 12% improvement in FEV1 (relative to baseline)
Time frame: Day 1
Peak Change From Baseline in IC on Day 1
Peak change from baseline in Inspiratory Capacity (IC) on Day 1 (mean of 1 and 2 hours post-dose minus baseline on Day 1)
Time frame: Day 1
Change From Baseline in Morning Pre-dose FEV1 on Day 7
Change from baseline in morning pre-dose FEV1
Time frame: Day 7
Peak Change From Baseline in FEV1 on Day 7
Peak change from baseline in FEV1
Time frame: Day 7
Peak Change From Baseline in IC on Day 7
Peak change from baseline in IC
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Pearl Investigative Site
Charlotte, North Carolina, United States
Pearl Investigative Site
Medford, Oregon, United States
Pearl Investigative Site
Longview, Texas, United States
Pearl Investigative Site
Richmond, Virginia, United States
Time frame: Day 7
Change From Baseline in 12-hour Post-dose Trough FEV1 on Day 7
Change from baseline in 12-hour post-dose trough FEV1
Time frame: Day 7