A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)



Status:Completed
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - 80
Updated:5/2/2018
Start Date:April 29, 2016
End Date:March 30, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD
exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6
μg, all administered BID.

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD
exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period.
Subjects who successfully complete the Screening Period will be randomized to one of the
following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all
administered BID. Following randomization, subjects will enter the Treatment Period and
undergo additional treatment visits over 52 weeks.

Inclusion Criteria:

1. Give their signed written informed consent to participate

2. At least 40 years of age and no older than 80 years of age

3. COPD patients who are symptomatic

4. Must be receiving one or more inhaled bronchodilators as maintenance therapy

5. Must have a documented history of COPD exacerbations

Exclusion Criteria:

1. Current diagnosis of asthma

2. COPD due to α1-Antitrypsin Deficiency

3. Known active tuberculosis, lung cancer, cystic fibrosis, and significant
bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6
months.

4. Long-term-oxygen therapy (≥ 15 hours a day).
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Aurora, Illinois 60506
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Austin, Texas 78744
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Canton, Ohio 44718
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Costa Mesa, California 92626
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Cumberland, Rhode Island 02864
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Dallas, Texas 75390
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Decatur, Georgia 30033
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Dothan, Alabama 36303
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East Providence, Rhode Island 02915
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Edmond, Oklahoma 73013
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Everett, Washington 98201
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Flagstaff, Arizona 86001
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Iowa City, Iowa 52242
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Kerrville, Texas 78028
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Kissimmee, Florida 34741
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Knoxville, Tennessee 37920
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Lancaster, South Carolina 29720
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Leesburg, Florida 34748
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Miami, Florida 33136
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Milwaukee, Wisconsin 53226
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Peoria, Illinois 61603
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Plano, Texas 75024
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Sherman, Texas 75090
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