Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)
A Randomized, Double-Blind, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD (Ethos)
1 other identifier
interventional
8,588
24 countries
724
Brief Summary
This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2015
Typical duration for phase_3
724 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2015
CompletedFirst Posted
Study publicly available on registry
June 8, 2015
CompletedStudy Start
First participant enrolled
June 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2019
CompletedResults Posted
Study results publicly available
February 2, 2021
CompletedFebruary 2, 2021
January 1, 2021
4.1 years
May 29, 2015
June 26, 2020
February 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Adjusted Rate of Moderate or Severe Exacerbations
Adjusted Rate of Moderate or Severe Exacerbations
52-week treatment period
Secondary Outcomes (5)
Time to First Moderate or Severe COPD Exacerbation
52 Weeks
Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks
24 Weeks
Percentage of Subjects Achieving a MCID of 4 Units or More in SGRQ Total Score
at Week 24
Time to Death (All Cause)
52 Weeks
Rate of Severe COPD Exacerbations
52 Weeks
Study Arms (4)
BGF (PT010) MDI 320/14.4/9.6 μg
EXPERIMENTALBGF MDI 320/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler \[MDI\])
BGF (PT010) MDI 160/14.4/9.6 μg
EXPERIMENTALBGF MDI 160/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler \[MDI\])
BFF (PT009) MDI 320/9.6 μg
EXPERIMENTALBFF MDI 320/9.6 μg Budesonide, Formoterol Fumarate Aerosol Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT009)
GFF (PT003) MDI 14.4/9.6 μg
EXPERIMENTALGFF MDI 14.4/9.6 μg Glycopyrronium, Formoterol Fumarate Aerosol Budesonide and Formoterol Fumarate Inhalation Aerosol (PT003)
Interventions
Budensonide, Glycopyrronium, and Formoterol Fumarate
Glycopyrronium, and Formoterol Fumarate
Budensonide, Glycopyrronium, and Formoterol Fumarate
Budensonide, and Formoterol Fumarate
Eligibility Criteria
You may qualify if:
- Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
- Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS),
- Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
- Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be \<0.70 and FEV1 must be \<65% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions).
- Subjects with history of exacerbations.
You may not qualify if:
- Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
- Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
- Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
- Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening)
- Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening)
- Immune suppression or severe neurological disorders affecting control of the upper airway or other risk factors that in the opinion of the Investigator would put the subject at substantial risk of pneumonia.
- Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the Investigator, have not been adequately treated.
- Subjects who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any other component of the IMPs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (741)
Research Site
Andalusia, Alabama, 36420, United States
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Athens, Alabama, 35611, United States
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Birmingham, Alabama, 35209, United States
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Birmingham, Alabama, 35235, United States
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Birmingham, Alabama, 35243, United States
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Dothan, Alabama, 36303, United States
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Florence, Alabama, 35630, United States
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Foley, Alabama, 36535, United States
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Gulf Shores, Alabama, 36542, United States
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Jasper, Alabama, 35501, United States
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Mobile, Alabama, 36608, United States
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Montgomery, Alabama, 36106, United States
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Scottsboro, Alabama, 35768, United States
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Sheffield, Alabama, 35660, United States
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Peoria, Arizona, 85381, United States
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Phoenix, Arizona, 85012, United States
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Phoenix, Arizona, 85018, United States
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Phoenix, Arizona, 85020, United States
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Scottsdale, Arizona, 85258, United States
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Conway, Arkansas, 72032, United States
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Little Rock, Arkansas, 72205, United States
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Little Rock, Arkansas, 72209, United States
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North Little Rock, Arkansas, 72117, United States
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Bakersfield, California, 93301, United States
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Beverly Hills, California, 90212, United States
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Cerritos, California, 90703, United States
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El Cajon, California, 92020, United States
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Escondido, California, 92025, United States
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Fresno, California, 93702, United States
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Gold River, California, 95670, United States
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Hawaiian Gardens, California, 90716, United States
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Huntington Beach, California, 92647, United States
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Huntington Park, California, 90255-6046, United States
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La Mirada, California, 90638, United States
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Lakewood, California, 90712, United States
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Los Angeles, California, 90017, United States
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Los Angeles, California, 90025, United States
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Los Angeles, California, 90036, United States
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Los Angeles, California, 90048, United States
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Newport Beach, California, 92663, United States
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Northridge, California, 91324, United States
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Palm Springs, California, 92262, United States
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Poway, California, 92064, United States
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Quartz Hill, California, 93536, United States
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Rancho Mirage, California, 92270, United States
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Riverside, California, 92506, United States
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Rolling Hills Estates, California, 90274, United States
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Sacramento, California, 95821, United States
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Sacramento, California, 95823, United States
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Sacramento, California, 95831, United States
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San Diego, California, 92117, United States
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San Diego, California, 92120, United States
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Santa Ana, California, 92704, United States
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Santa Ana, California, 92705, United States
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Santa Monica, California, 90404, United States
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Stockton, California, 95207, United States
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Torrance, California, 90503, United States
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Tustin, California, 92780, United States
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Upland, California, 91786, United States
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Westminster, California, 92683, United States
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Wildomar, California, 92595, United States
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Colorado Springs, Colorado, 80910, United States
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Colorado Springs, Colorado, 80922, United States
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Fort Collins, Colorado, 80525, United States
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Lafayette, Colorado, 80026, United States
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Boynton Beach, Florida, 33435, United States
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Brandon, Florida, 33511, United States
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Clearwater, Florida, 33756, United States
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Clearwater, Florida, 33765, United States
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Clermont, Florida, 34711, United States
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Coral Gables, Florida, 33134, United States
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Daytona Beach, Florida, 32117, United States
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Fort Lauderdale, Florida, 33308, United States
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Gainesville, Florida, 32607, United States
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Hialeah, Florida, 33012, United States
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Hialeah, Florida, 33029, United States
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Hollywood, Florida, 33024, United States
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Homestead, Florida, 33030, United States
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Kissimmee, Florida, 34741, United States
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Kissimmee, Florida, 34744, United States
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Leesburg, Florida, 34748, United States
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Loxahatchee Groves, Florida, 33470, United States
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Miami, Florida, 33012, United States
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Miami, Florida, 33125, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33144, United States
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Miami, Florida, 33155, United States
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Miami, Florida, 33165, United States
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Miami, Florida, 33174, United States
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Miami, Florida, 33175, United States
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Miami, Florida, 33186, United States
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Miami Lakes, Florida, 33014, United States
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Ormond Beach, Florida, 32174, United States
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Panama City, Florida, 32405, United States
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Pembroke Pines, Florida, 33029, United States
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Pensacola, Florida, 32503, United States
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Port Charlotte, Florida, 33952, United States
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Sarasota, Florida, 34239, United States
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St. Petersburg, Florida, 33704, United States
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St. Petersburg, Florida, 33707, United States
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St. Petersburg, Florida, 33710, United States
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Tampa, Florida, 33603, United States
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Tampa, Florida, 33607, United States
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Winter Park, Florida, 32789, United States
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Atlanta, Georgia, 30308, United States
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Atlanta, Georgia, 30328, United States
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Atlanta, Georgia, 30331, United States
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Atlanta, Georgia, 30345, United States
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Blue Ridge, Georgia, 30513, United States
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Columbus, Georgia, 31904, United States
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Dacula, Georgia, 30019, United States
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Duluth, Georgia, 30096, United States
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Lawrenceville, Georgia, 30046, United States
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Norcross, Georgia, 30071, United States
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Rincon, Georgia, 31326, United States
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Riverdale, Georgia, 30274, United States
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Savannah, Georgia, 31406, United States
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Woodstock, Georgia, 30189, United States
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Belleville, Illinois, 62220, United States
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Champaign, Illinois, 61820, United States
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Chicago, Illinois, 60607, United States
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O'Fallon, Illinois, 62269, United States
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Skokie, Illinois, 60076, United States
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Michigan City, Indiana, 46360, United States
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Valparaiso, Indiana, 46383, United States
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Council Bluffs, Iowa, 51503, United States
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West Des Moines, Iowa, 50266, United States
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Fort Mitchell, Kentucky, 41017, United States
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Owensboro, Kentucky, 42303, United States
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Paducah, Kentucky, 42003, United States
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Crowley, Louisiana, 70526, United States
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Lafayette, Louisiana, 70508, United States
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Lake Charles, Louisiana, 70601, United States
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New Orleans, Louisiana, 70115, United States
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Opelousas, Louisiana, 70570, United States
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Sunset, Louisiana, 70584, United States
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Zachary, Louisiana, 70791, United States
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Bangor, Maine, 04401, United States
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Baltimore, Maryland, 21224, United States
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Baltimore, Maryland, 21236, United States
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Baltimore, Maryland, 21237, United States
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Columbia, Maryland, 21044, United States
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White Marsh, Maryland, 21162, United States
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Marlborough, Massachusetts, 01752, United States
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Methuen, Massachusetts, 01844, United States
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North Dartmouth, Massachusetts, 02747, United States
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Buckley, Michigan, 49620, United States
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Cadillac, Michigan, 49601, United States
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Canton, Michigan, 48187, United States
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Caro, Michigan, 48723, United States
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Farmington Hills, Michigan, 48336, United States
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Flint, Michigan, 48504, United States
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Port Huron, Michigan, 48060, United States
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Rochester, Michigan, 48307, United States
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Southfield, Michigan, 48034, United States
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Troy, Michigan, 48085, United States
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Edina, Minnesota, 55435, United States
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Fridley, Minnesota, 55432, United States
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Minneapolis, Minnesota, 55407, United States
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Woodbury, Minnesota, 55125, United States
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Biloxi, Mississippi, 39531, United States
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Belton, Missouri, 64012, United States
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Chesterfield, Missouri, 63017, United States
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Saint Charles, Missouri, 63301, United States
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St Louis, Missouri, 63141, United States
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St Louis, Missouri, 63143, United States
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Billings, Montana, 59102, United States
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Bellevue, Nebraska, 68005, United States
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Bellevue, Nebraska, 68123, United States
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Las Vegas, Nevada, 89106, United States
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Reno, Nevada, 89519, United States
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Portsmouth, New Hampshire, 03801, United States
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Marlton, New Jersey, 08053, United States
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Toms River, New Jersey, 08755, United States
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Bronxville, New York, 10708, United States
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Brooklyn, New York, 11229, United States
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Jamaica, New York, 11435, United States
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New Windsor, New York, 12553, United States
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New York, New York, 10016, United States
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The Bronx, New York, 10455, United States
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The Bronx, New York, 10457, United States
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The Bronx, New York, 10459, United States
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The Bronx, New York, 10461, United States
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The Bronx, New York, 10468, United States
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Asheville, North Carolina, 28801, United States
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Burlington, North Carolina, 27215, United States
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Charlotte, North Carolina, 28207, United States
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Charlotte, North Carolina, 28210, United States
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Charlotte, North Carolina, 28277, United States
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Elizabeth City, North Carolina, 27909, United States
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Gastonia, North Carolina, 28054, United States
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Greensboro, North Carolina, 27408, United States
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Hendersonville, North Carolina, 28739, United States
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Hickory, North Carolina, 28601, United States
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Huntersville, North Carolina, 28078, United States
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Lenoir, North Carolina, 28645, United States
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Monroe, North Carolina, 28112, United States
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Mooresville, North Carolina, 28117, United States
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Morganton, North Carolina, 28655, United States
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Mount Airy, North Carolina, 27030, United States
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New Bern, North Carolina, 28562, United States
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Raleigh, North Carolina, 27612, United States
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Shelby, North Carolina, 28150, United States
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Whiteville, North Carolina, 28472, United States
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Wilmington, North Carolina, 28401, United States
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Winston-Salem, North Carolina, 27103, United States
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Fargo, North Dakota, 58104, United States
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Blue Ash, Ohio, 45242, United States
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Cincinnati, Ohio, 45231, United States
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Cincinnati, Ohio, 45245, United States
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Columbus, Ohio, 43123, United States
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Dayton, Ohio, 45419, United States
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Dayton, Ohio, 45459, United States
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Dublin, Ohio, 43016, United States
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Kettering, Ohio, 45429, United States
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Maumee, Ohio, 43537, United States
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Toledo, Ohio, 43617, United States
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Edmond, Oklahoma, 73034, United States
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Oklahoma City, Oklahoma, 73103, United States
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Tulsa, Oklahoma, 74136, United States
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Medford, Oregon, 97504, United States
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Portland, Oregon, 97202, United States
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Altoona, Pennsylvania, 16602, United States
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Erie, Pennsylvania, 16508, United States
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Monroeville, Pennsylvania, 15665, United States
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Philadelphia, Pennsylvania, 19114, United States
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Phoenixville, Pennsylvania, 19460, United States
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Pittsburgh, Pennsylvania, 15236, United States
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Pittsburgh, Pennsylvania, 15241, United States
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Pittsburgh, Pennsylvania, 15243, United States
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Scottdale, Pennsylvania, 15683, United States
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Uniontown, Pennsylvania, 15401, United States
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East Providence, Rhode Island, 02914, United States
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Providence, Rhode Island, 02908, United States
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Anderson, South Carolina, 29621, United States
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Charleston, South Carolina, 29406, United States
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Charleston, South Carolina, 29412, United States
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Columbia, South Carolina, 29201, United States
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Easley, South Carolina, 29640, United States
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Gaffney, South Carolina, 29340, United States
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Gaffney, South Carolina, 29341, United States
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Greenville, South Carolina, 29615, United States
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Greer, South Carolina, 29650, United States
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Greer, South Carolina, 29651, United States
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Hodges, South Carolina, 29653, United States
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Lancaster, South Carolina, 29720, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Old Point Station, South Carolina, 29707, United States
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Rock Hill, South Carolina, 29732, United States
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Seneca, South Carolina, 29678, United States
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Spartanburg, South Carolina, 29301, United States
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Spartanburg, South Carolina, 29303, United States
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Union, South Carolina, 29379, United States
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Rapid City, South Dakota, 57702, United States
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Chattanooga, Tennessee, 37404, United States
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Hendersonville, Tennessee, 37075, United States
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Johnson City, Tennessee, 37601, United States
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Knoxville, Tennessee, 37912, United States
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Arlington, Texas, 76012, United States
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Arlington, Texas, 76014, United States
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Boerne, Texas, 78006, United States
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Carrollton, Texas, 75007, United States
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Corsicana, Texas, 75110, United States
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Cypress, Texas, 77429, United States
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Duncanville, Texas, 75116, United States
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El Paso, Texas, 79903, United States
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Fort Worth, Texas, 76104, United States
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Fort Worth, Texas, 76109, United States
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Houston, Texas, 77008, United States
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Houston, Texas, 77043, United States
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Houston, Texas, 77058, United States
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Houston, Texas, 77070, United States
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Houston, Texas, 77074, United States
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Houston, Texas, 77079, United States
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Houston, Texas, 77084, United States
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Houston, Texas, 77089, United States
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Houston, Texas, 77099, United States
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Huntsville, Texas, 77340, United States
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Katy, Texas, 77450, United States
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Kerrville, Texas, 78028, United States
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Killeen, Texas, 76543, United States
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Kingwood, Texas, 77339, United States
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Lampasas, Texas, 76550, United States
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Lewisville, Texas, 75067, United States
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Longview, Texas, 75605, United States
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Lufkin, Texas, 75904, United States
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McKinney, Texas, 75069, United States
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McKinney, Texas, 75071, United States
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Pearland, Texas, 77584, United States
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Pflugerville, Texas, 78660, United States
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Plano, Texas, 75093, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78258, United States
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Sealy, Texas, 77474, United States
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Sherman, Texas, 75092, United States
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Splendora, Texas, 77372, United States
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The Woodlands, Texas, 77380, United States
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Webster, Texas, 77598, United States
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Midvale, Utah, 84047, United States
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Salt Lake City, Utah, 84102, United States
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Abingdon, Virginia, 24210, United States
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Burke, Virginia, 22015, United States
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Newport News, Virginia, 23606, United States
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Richmond, Virginia, 23114, United States
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Richmond, Virginia, 23219, United States
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Richmond, Virginia, 23220, United States
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Richmond, Virginia, 23225, United States
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Richmond, Virginia, 23230, United States
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Richmond, Virginia, 23235, United States
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Virginia Beach, Virginia, 23454, United States
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Williamsburg, Virginia, 23188, United States
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Bellevue, Washington, 98007, United States
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Richland, Washington, 99352, United States
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Spokane, Washington, 99202, United States
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Spokane, Washington, 99216, United States
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Tacoma, Washington, 98405, United States
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Morgantown, West Virginia, 26505, United States
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Greenfield, Wisconsin, 53228, United States
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Buenos Aires, 1015, Argentina
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Buenos Aires, C1121ABE, Argentina
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Buenos Aires, C1414AIF, Argentina
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Buenos Aires, C1425BEN, Argentina
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CABA, C1056ABJ, Argentina
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Capital Federal, C1122AAK, Argentina
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Ciudad Autonoma de Buenos Aire, C1028AAP, Argentina
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Ciudad Autonoma de Buenos Aire, C1120AAC, Argentina
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Ciudad Autonomade Buenos Aires, 1426, Argentina
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Ciudad Autónoma de Bs. As., 1426, Argentina
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Ciudad Capital, 5500, Argentina
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Ciudad de Buenos Aire, C1425BEN, Argentina
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Córdoba, X5003DCE, Argentina
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Córdoba, X5008HHW, Argentina
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Florida, B1602DQD, Argentina
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La Plata, 1900, Argentina
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Lanús, B1824KAJ, Argentina
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Mar del Plata, 7600, Argentina
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Mar del Plata, B7600FZN, Argentina
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Mendoza, 5500, Argentina
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Mendoza, M5500GIP, Argentina
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Mendoza, M5500GPD, Argentina
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Monte Grande, 1842, Argentina
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Paraná, E3100XAI, Argentina
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Quilmes, B1878FNR, Argentina
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Rosario, 2000, Argentina
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Rosario, 2002, Argentina
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Rosario, S2000DEJ, Argentina
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San Fernando, 1646, Argentina
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San Juan Bautista, 1888, Argentina
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San Miguel de Tucumán, 4000, Argentina
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San Miguel de Tucumán, T4000IAR, Argentina
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Santa Fe, S3000ASF, Argentina
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Santa Fe, S3000FWO, Argentina
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Santa Rosa, L6300EAN, Argentina
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Adelaide, 5000, Australia
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Bedford Park, 5042, Australia
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Box Hill, 3128, Australia
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Cairns, 4870, Australia
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Concord, 2139, Australia
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Everton Park, 4053, Australia
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Kent Town, 5067, Australia
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Murdoch, 6150, Australia
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Nedlands, 6009, Australia
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South Brisbane, 4101, Australia
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Westmead, 2145, Australia
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Feldbach, A-8330, Austria
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Grieskirchen, 4710, Austria
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Hallein, 5400, Austria
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Linz, 04020, Austria
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Salzburg, 5020, Austria
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Thalheim, 4600, Austria
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Vienna, 1190, Austria
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Wels, 4600, Austria
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Brussels, 1200, Belgium
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Erpent, 5101, Belgium
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Genk, 03600, Belgium
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Gilly, 6060, Belgium
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Halen, 03545, Belgium
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Ham, 03945, Belgium
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Lebbeke, Belgium
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Montigny-le-Tilleul, BE-6110, Belgium
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Wetteren, 9230, Belgium
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Edmonton, Alberta, T5A 4L8, Canada
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Sherwood Park, Alberta, T8L 0N2, Canada
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Vancouver, British Columbia, V5X04, Canada
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Vancouver, CA, V5Z 4E1, Canada
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Winnipeg, Manitoba, R2K 3S8, Canada
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Truro, Nova Scotia, B2N 1L2, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Greater Sudbury, Ontario, P3A 1W8, Canada
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Hamilton, Ontario, L8N 4A6, Canada
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Mississauga, Ontario, L4V 1P1, Canada
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Sarnia, Ontario, N7T4X3, Canada
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Windsor, Ontario, N8X 1T3, Canada
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Gatineau, Quebec, J8Y 6S8, Canada
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Lévis, Quebec, G6W 0M5, Canada
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Mirabel, Quebec, J7J 2K8, Canada
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Montreal, Quebec, H1M 1B1, Canada
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Related Publications (5)
Muro S, Seki M, Hurst JR, Petullo D, Marshall J, Bowen K, Darken PF, Duncan EA, Megally A, Patel M. Triple Therapy with Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate versus Dual Therapies for Patients with COPD and Phenotypic Features of Asthma: A Pooled Post Hoc Analysis of KRONOS and ETHOS. Int J Chron Obstruct Pulmon Dis. 2024 Dec 12;19:2729-2737. doi: 10.2147/COPD.S478349. eCollection 2024.
PMID: 39691156DERIVEDSingh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.
PMID: 35815359DERIVEDRhodes K, Jenkins M, de Nigris E, Aurivillius M, Ouwens M. Relationship between risk, cumulative burden of exacerbations and mortality in patients with COPD: modelling analysis using data from the ETHOS study. BMC Med Res Methodol. 2022 May 25;22(1):150. doi: 10.1186/s12874-022-01616-7.
PMID: 35614467DERIVEDRabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Aurivillius M, Reisner C, Dorinsky P; ETHOS Investigators. Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD. N Engl J Med. 2020 Jul 2;383(1):35-48. doi: 10.1056/NEJMoa1916046. Epub 2020 Jun 24.
PMID: 32579807DERIVEDRabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Reisner C, Dorinsky P. A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6 mug and 160/18/9.6 mug using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol. Respir Med. 2019 Oct-Nov;158:59-66. doi: 10.1016/j.rmed.2019.08.010. Epub 2019 Aug 22.
PMID: 31605923DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pearl Therapeutics Inc
- Organization
- Pearl Therapeutics Inc
Study Officials
- STUDY DIRECTOR
Paul M Dorinsky, MD
Pearl Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2015
First Posted
June 8, 2015
Study Start
June 30, 2015
Primary Completion
July 26, 2019
Study Completion
July 26, 2019
Last Updated
February 2, 2021
Results First Posted
February 2, 2021
Record last verified: 2021-01