Study to Evaluate the Safety and Efficacy of Inhaled PT005 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00880490 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2010-10-13
Summary
The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 compared to placebo and Formoterol Fumarate (Foradil Aerolizer) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Conditions
Interventions
- DRUG
-
Inhaled PT005
single dose, inhaled
- DRUG
-
Inhaled PT005
single dose, inhaled
- DRUG
-
Inhaled PT005
single dose, inhaled
- DRUG
-
Inhaled placebo
single dose, inhaled
- DRUG
-
Formoterol Fumarate 12 mcg (Foradil Aerolizer)
single dose, Formoterol Fumarate 12 mcg administered via the Aerolizer
Sponsors & Collaborators
-
Pearl Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Colin Reisner, M.D. · Pearl Therapeutics, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-11-30
- Primary Completion
- 2009-05-31
- Completion
- 2009-05-31
Countries
- Australia
- New Zealand
Study Locations
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