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).
We found this trial at
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Clinical Trial Facility in Buenos Aires
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Clinical Trial Facility in Aurora Illinois
Aurora, Illinois 60506
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Austin, Texas 78744
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Boynton Beach, Florida 33472
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Clinical Trial Facility in Bronx New York
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Brooklyn, New York 11215
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Clinical Trial Facility in Brownsburg Indiana
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Clinical Trial Facility in Canton Ohio
Canton, Ohio 44718
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Clinical Trial Facility in Chesterfield Missouri
Chesterfield, Missouri
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Clinical Trial Facility in Chicago Illinois
Chicago, Illinois
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Clinical Trial Facility in Chiefland Florida
Chiefland, Florida 32626
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Cincinnati, Ohio
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Clinical Trial Facility in Clearwater Florida
Clearwater, Florida 33756
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Clinical Trial Facility in Columbus Ohio
Columbus, Ohio 43214
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Costa Mesa, California 92626
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Clinical Trial Facility in Cumberland Rhode Island
Cumberland, Rhode Island 02864
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Clinical Trial Facility in Dacula Georgia
123 Broad Street
Dacula, Georgia 30019
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Clinical Trial Facility in Dallas Texas
Dallas, Texas 75390
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Clinical Trial Facility in Dayton Ohio
Dayton, Ohio 45409
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Daytona Beach, Florida 32117
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Clinical Trial Facility in Decatur Georgia
Decatur, Georgia 30033
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Clinical Trial Facility in Denver Colorado
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Dothan, Alabama 36303
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Clinical Trial Facility in East Providence Rhode Island
East Providence, Rhode Island 02915
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Clinical Trial Facility in Edmond Oklahoma
Edmond, Oklahoma 73013
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Evansville, Indiana 47713
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Clinical Trial Facility in Everett Washington
Everett, Washington 98201
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Clinical Trial Facility in Flagstaff Arizona
Flagstaff, Arizona 86001
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Franklin, Tennessee 37067
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Gastonia, North Carolina 28054
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Hazard, Kentucky 41701
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Hickory, North Carolina 28601
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Huntsville, Alabama 35801
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Iowa City, Iowa 52242
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Johnstown, Pennsylvania 15905
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Kansas City, Missouri 64108
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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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Lehigh Acres, Florida 33971
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Lenoir, North Carolina 28645
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Lewisville, Texas 75067
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Lincoln, California 95648
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Lincoln, Nebraska 68515
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Manassas, Virginia 20109
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Clinical Trial Facility in Marion Ohio
Marion, Ohio 43302
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Medford, Oregon 97504
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Clinical Trial Facility in Metairie Louisiana
Metairie, Louisiana 70006
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Clinical Trial Facility in Miami Florida
Miami, Florida 33136
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Clinical Trial Facility in Milwaukee Wisconsin
Milwaukee, Wisconsin 53226
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Clinical Trial Facility in New Haven Connecticut
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New York, New York 10032
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Orlando, Florida 32804
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Ormond Beach, Florida 32174
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Palo Alto, California 94301
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Clinical Trial Facility in Peoria Illinois
Peoria, Illinois 61603
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Clinical Trial Facility in Plano Texas
Plano, Texas 75024
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Port Arthur, Texas 77640
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Reno, Nevada 89502
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Renton, Washington 98057
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Rochester, Minnesota 55905
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Saint Louis, Missouri 63110
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Sarasota, Florida 34239
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Clinical Trial Facility in Sherman Texas
Sherman, Texas 75090
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Smyrna, Tennessee 37167
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Spartanburg, South Carolina 29303
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Sunset, Louisiana 70584
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Syracuse, New York 13202
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Tabor City, North Carolina 28463
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Toms River, New Jersey 08755
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