Study identifier:PT001002
ClinicalTrials.gov identifier:NCT01350128
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomized, Double-Blind, Chronic Dosing (7 Days), Three-Period, Six-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Four Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Atrovent® HFA Inhalation Aerosol (Open-Label) as An Active Control
Chronic Obstructive Pulmonary Disease
Phase 2
No
PT001 MDI, Ipratropium Bromide HFA Inhalation Aerosol
All
103
Interventional
40 Years - 80 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 May 2018 by Pearl Therapeutics, Inc.
Pearl Therapeutics, Inc.
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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.
Location
Location
Medford, Oregon, United States
Location
Charlotte, North Carolina, United States
Location
Summit, New Jersey, United States
Location
Panama City, Florida, United States
Location
Winter Park, Florida, United States
Location
Cherry Hill, New Jersey, United States
Location
Richmond, Virginia, United States
Location
Longview, Texas, United States
Arms | Assigned Interventions |
---|---|
Experimental: PT001 MDI (Dose 1) PT001 MDI | Drug: PT001 MDI PT001 MDI administered as two puffs BID for 7 days |
Experimental: PT001 MDI (Dose 2) PT001 MDI | Drug: PT001 MDI PT001 MDI administered as two puffs BID for 7 days |
Experimental: PT001 MDI (Dose 3) PT001 MDI | Drug: PT001 MDI PT001 MDI administered as two puffs BID for 7 days |
Experimental: PT001 MDI (Dose 4) PT001 MDI | Drug: PT001 MDI PT001 MDI administered as two puffs BID for 7 days |
Active Comparator: Ipratropium Bromide HFA Inhalation Aerosol Ipratropium Bromide HFA Inhalation Aerosol | Drug: Ipratropium Bromide HFA Inhalation Aerosol Taken as 2 inhalations of the 17 µg per actuation strength MDI QID Other Name: Atrovent |
Placebo Comparator: Placebo MDI PT001 Placebo MDI | Other: Placebo MDI Matching placebo to PT001 MDI administered as two puffs BID for 7 days |
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