PT003
DrugPT003 MDI administered as two puffs BID for 7 days
NCT Number: NCT01349816
The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
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Notify Me40 year–80 year
All sexes
Interventional
Phase 2
Pearl Investigative Site, Rancho Mirage, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other inclusion/exclusion criteria as defined in the protocol
PT003 MDI administered as two puffs BID for 7 days
PT001 MDI administered as two puffs BID for 7 days
PT005 MDI administered as two puffs BID for 7 days
Time frame: Day 7
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week).
Time frame: Day 1
Peak change from baseline in FEV1 through 2 hours
Time frame: Day 1
At least 10% improvement in mean FEV1
Time frame: Day 1
Proportion of subjects achieving >=12% improvement in FEV1 relative to baseline
Time frame: Day 1
Mean inspiratory capacity (IC) of 1 and 2 hours post-dose minus baseline
Time frame: Day 7
Change from baseline in morning pre-dose FEV1 (average of 60- and 30-minute pre-dose values on Day 7)
Time frame: Day 7
Peak change from baseline in FEV1 through 6 hours
Time frame: Day 7
Peak change from baseline in inspiratory capacity (IC) (mean of 1 and 2 hours post-dose minus baseline)
Time frame: Day 7
Change from baseline in mean evening 12-hour post-dose trough FEV1
Pearl Therapeutics, Inc.
Industry
A Randomized, Double Blind, Chronic Dosing (7 Days), Two Period, Six Treatment, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Four Doses of PT003 MDI in Patients With Moderate to Severe COPD, Compared With Its Individual Components (PT005 MDI and PT001 MDI) as Active Controls
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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