Study identifier:PT0010801
ClinicalTrials.gov identifier:NCT00871182
EudraCT identifier:N/A
CTIS identifier:N/A
A randomized, double-blind, single dose, four-period, six-treatment, placebo-controlled, balanced, incomplete block, cross-over, study of four doses of inhaled PT001 in patients with mild to moderate COPD, compared to open label tiotropium
Chronic Obstructive Pulmonary Disease
-
No
Inhaled PT001, Inhaled Placebo, Tiotropium Handihaler
All
33
Interventional
40 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Apr 2016 by Pearl Therapeutics, Inc.
Pearl Therapeutics, Inc.
-
The purpose of this study is to evaluate the safety and efficacy of inhaled PT001 compared to placebo and tiotropium in patients with mild to moderate chronic obstructive pulmonary disease (COPD).
Location
Location
Denver, CO, United States, 80206
Location
Miami, FL, United States, 33169
Location
Omaha, NE, United States, 68198
Location
Spartanburg, SC, United States, 29303
Location
Cincinnati, OH, United States, 45220
Location
Peoria, AZ, United States, 85381
Arms | Assigned Interventions |
---|---|
Experimental: PT001 18 mcg Inhaled PT001 18 mcg | Drug: Inhaled PT001 single dose, inhaled |
Experimental: PT001 36 mcg Inhaled PT001 36 mcg | Drug: Inhaled PT001 single dose, inhaled |
Experimental: PT001 72 mcg Inhaled PT001 72 mcg | Drug: Inhaled PT001 single dose, inhaled |
Experimental: PT001 144 mcg Inhaled PT001 144 mcg | Drug: Inhaled PT001 single dose, inhaled |
Placebo Comparator: Inhaled Placebo Inhaled Placebo | Drug: Inhaled Placebo single dose, inhaled |
Active Comparator: Tiotropium Handihaler Tiotropium 18 mcg administered via Handihaler | Drug: Tiotropium Handihaler single dose, tiotropium 18 mcg administered via the Handihaler Other Name: Spiriva |
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