Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)
NCT ID: NCT02465567
Last Updated: 2021-02-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
8588 participants
INTERVENTIONAL
2015-06-30
2019-07-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BGF (PT010) MDI 320/14.4/9.6 μg
BGF MDI 320/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler \[MDI\])
BGF MDI 320/14.4/9.6 μg
Budensonide, Glycopyrronium, and Formoterol Fumarate
BGF (PT010) MDI 160/14.4/9.6 μg
BGF MDI 160/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler \[MDI\])
BGF MDI 160/14.4/9.6 μg
Budensonide, Glycopyrronium, and Formoterol Fumarate
BFF (PT009) MDI 320/9.6 μg
BFF MDI 320/9.6 μg Budesonide, Formoterol Fumarate Aerosol Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT009)
BFF MDI 320/9.6 μg
Budensonide, and Formoterol Fumarate
GFF (PT003) MDI 14.4/9.6 μg
GFF MDI 14.4/9.6 μg Glycopyrronium, Formoterol Fumarate Aerosol Budesonide and Formoterol Fumarate Inhalation Aerosol (PT003)
GFF MDI 14.4/9.6 μg
Glycopyrronium, and Formoterol Fumarate
Interventions
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BGF MDI 320/14.4/9.6 μg
Budensonide, Glycopyrronium, and Formoterol Fumarate
GFF MDI 14.4/9.6 μg
Glycopyrronium, and Formoterol Fumarate
BGF MDI 160/14.4/9.6 μg
Budensonide, Glycopyrronium, and Formoterol Fumarate
BFF MDI 320/9.6 μg
Budensonide, and Formoterol Fumarate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
40 Years
80 Years
ALL
No
Sponsors
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Pearl Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paul M Dorinsky, MD
Role: STUDY_DIRECTOR
Pearl Therapeutics
Locations
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Andalusia, Alabama, United States
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Athens, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Florence, Alabama, United States
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Foley, Alabama, United States
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Gulf Shores, Alabama, United States
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Jasper, Alabama, United States
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Mobile, Alabama, United States
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Montgomery, Alabama, United States
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Scottsboro, Alabama, United States
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Sheffield, Alabama, United States
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Peoria, Arizona, United States
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Scottsdale, Arizona, United States
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Conway, Arkansas, United States
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Little Rock, Arkansas, United States
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Little Rock, Arkansas, United States
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North Little Rock, Arkansas, United States
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Bakersfield, California, United States
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Beverly Hills, California, United States
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Cerritos, California, United States
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El Cajon, California, United States
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Escondido, California, United States
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Fresno, California, United States
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Gold River, California, United States
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Hawaiian Gardens, California, United States
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Huntington Beach, California, United States
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Huntington Park, California, United States
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La Mirada, California, United States
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Lakewood, California, United States
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Newport Beach, California, United States
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Northridge, California, United States
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Palm Springs, California, United States
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Poway, California, United States
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Quartz Hill, California, United States
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Rancho Mirage, California, United States
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Riverside, California, United States
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Rolling Hills Estates, California, United States
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Sacramento, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Santa Ana, California, United States
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Santa Monica, California, United States
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Stockton, California, United States
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Torrance, California, United States
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Tustin, California, United States
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Upland, California, United States
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Westminster, California, United States
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Wildomar, California, United States
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Colorado Springs, Colorado, United States
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Colorado Springs, Colorado, United States
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Fort Collins, Colorado, United States
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Lafayette, Colorado, United States
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Boynton Beach, Florida, United States
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Brandon, Florida, United States
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Riverdale, Georgia, United States
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Savannah, Georgia, United States
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Woodstock, Georgia, United States
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Belleville, Illinois, United States
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Champaign, Illinois, United States
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Chicago, Illinois, United States
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O'Fallon, Illinois, United States
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Skokie, Illinois, United States
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Michigan City, Indiana, United States
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Valparaiso, Indiana, United States
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Council Bluffs, Iowa, United States
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West Des Moines, Iowa, United States
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Fort Mitchell, Kentucky, United States
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Owensboro, Kentucky, United States
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Paducah, Kentucky, United States
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Crowley, Louisiana, United States
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Lafayette, Louisiana, United States
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Lake Charles, Louisiana, United States
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New Orleans, Louisiana, United States
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Bangor, Maine, United States
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Biloxi, Mississippi, United States
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Chesterfield, Missouri, United States
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Las Vegas, Nevada, United States
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Portsmouth, New Hampshire, United States
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Marlton, New Jersey, United States
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Jamaica, New York, United States
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Kettering, Ohio, United States
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Maumee, Ohio, United States
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Toledo, Ohio, United States
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Tulsa, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Altoona, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Monroeville, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Phoenixville, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Scottdale, Pennsylvania, United States
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Uniontown, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Providence, Rhode Island, United States
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Anderson, South Carolina, United States
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Charleston, South Carolina, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Easley, South Carolina, United States
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Gaffney, South Carolina, United States
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Gaffney, South Carolina, United States
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Greenville, South Carolina, United States
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Greer, South Carolina, United States
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Greer, South Carolina, United States
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Hodges, South Carolina, United States
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Lancaster, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Old Point Station, South Carolina, United States
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Rock Hill, South Carolina, United States
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Seneca, South Carolina, United States
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Spartanburg, South Carolina, United States
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Spartanburg, South Carolina, United States
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Union, South Carolina, United States
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Rapid City, South Dakota, United States
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Chattanooga, Tennessee, United States
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Hendersonville, Tennessee, United States
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Johnson City, Tennessee, United States
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Knoxville, Tennessee, United States
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Arlington, Texas, United States
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Arlington, Texas, United States
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Boerne, Texas, United States
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Carrollton, Texas, United States
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Corsicana, Texas, United States
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Cypress, Texas, United States
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Duncanville, Texas, United States
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El Paso, Texas, United States
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Huntsville, Texas, United States
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Katy, Texas, United States
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Kerrville, Texas, United States
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Killeen, Texas, United States
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Kingwood, Texas, United States
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Lampasas, Texas, United States
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Lewisville, Texas, United States
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Longview, Texas, United States
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Lufkin, Texas, United States
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McKinney, Texas, United States
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McKinney, Texas, United States
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Pearland, Texas, United States
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Pflugerville, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Sealy, Texas, United States
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Sherman, Texas, United States
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Splendora, Texas, United States
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The Woodlands, Texas, United States
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Webster, Texas, United States
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Midvale, Utah, United States
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Salt Lake City, Utah, United States
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Abingdon, Virginia, United States
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Burke, Virginia, United States
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Newport News, Virginia, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Virginia Beach, Virginia, United States
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Williamsburg, Virginia, United States
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Bellevue, Washington, United States
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Richland, Washington, United States
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Spokane, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Morgantown, West Virginia, United States
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Greenfield, Wisconsin, United States
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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CABA, , Argentina
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Capital Federal, , Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Ciudad Autónoma de Bs. As., , Argentina
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Ciudad Capital, , Argentina
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Córdoba, , Argentina
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Florida, , Argentina
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La Plata, , Argentina
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Mendoza, , Argentina
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Adelaide, , Australia
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Wetteren, , Belgium
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Edmonton, Alberta, Canada
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Sherwood Park, Alberta, Canada
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Vancouver, British Columbia, Canada
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Truro, Nova Scotia, Canada
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Ajax, Ontario, Canada
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Hamilton, Ontario, Canada
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Pointe-Claire, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Xiangtan, , China
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Zhanjiang, , China
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Benešov, , Czechia
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Beroun, , Czechia
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Jindřichův Hradec, , Czechia
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Liberec, , Czechia
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Liberec, , Czechia
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Mělník, , Czechia
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Moravský Krumlov, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Teplice, , Czechia
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Žatec, , Czechia
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Lyon, , France
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Marseille, , France
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Nantes, , France
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Nîmes, , France
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Vandœuvre-lès-Nancy, , France
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Aschaffenburg, , Germany
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Augsburg, , Germany
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Bad Wörishofen, , Germany
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Bamberg, , Germany
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Berlin, , Germany
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Bonn, , Germany
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Bonn, , Germany
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Cologne, , Germany
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Cottbus, , Germany
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Darmstadt, , Germany
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Deggendorf, , Germany
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Deggingen, , Germany
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Dortmund, , Germany
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Düren, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Frankfurt am Main, , Germany
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Frankfurt am Main, , Germany
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Gelsenkirchen, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Hanover, , Germany
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Hanover, , Germany
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Ibbenbueren, , Germany
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Kiel, , Germany
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Koblenz, , Germany
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Landsberg, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Lübeck, , Germany
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Magdeburg, , Germany
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Mainz, , Germany
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Marburg, , Germany
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München, , Germany
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München, , Germany
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Münster, , Germany
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Neu-Isenburg, , Germany
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Peine, , Germany
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Potsdam, , Germany
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Radebeul, , Germany
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Rosenheim, , Germany
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Rüdersdorf, , Germany
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Rüsselsheim am Main, , Germany
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Schleswig, , Germany
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Schwedt, , Germany
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Wardenburg, , Germany
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Weinheim, , Germany
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Wiesbaden, , Germany
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Wiesloch, , Germany
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Witten, , Germany
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Zerbst, , Germany
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Balassagyarmat, , Hungary
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Budapest, , Hungary
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Csorna, , Hungary
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Debrecen, , Hungary
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Gödöllő, , Hungary
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Kaposvár, , Hungary
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Kapuvár, , Hungary
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Komárom, , Hungary
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Komló, , Hungary
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Miskolc, , Hungary
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Nyíregyháza, , Hungary
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Siófok, , Hungary
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Százhalombatta, , Hungary
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Szigetszentmiklós, , Hungary
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Törökbálint, , Hungary
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Bologna, , Italy
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Foggia, , Italy
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Genova, , Italy
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Messina, , Italy
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Milan, , Italy
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Modena, , Italy
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Napoli, , Italy
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Palermo, , Italy
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Parma, , Italy
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Pisa, , Italy
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Pordenone, , Italy
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Roma, , Italy
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Roma, , Italy
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Roma, , Italy
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Tradate, , Italy
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Osakasayama-shi, , Japan
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Seto-shi, , Japan
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Cuautitlán Izcalli, , Mexico
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Monterrey, , Mexico
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Almelo, , Netherlands
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Beek, , Netherlands
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Breda, , Netherlands
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Capelle aan den IJssel, , Netherlands
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Eindhoven, , Netherlands
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Enschede, , Netherlands
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Harderwijk, , Netherlands
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Heerlen, , Netherlands
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Hoorn, , Netherlands
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Voerendaal, , Netherlands
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Zutphen, , Netherlands
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Zwolle, , Netherlands
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Auckland, , New Zealand
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Christchurch, , New Zealand
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Christchurch, , New Zealand
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Dunedin, , New Zealand
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Greenlane, , New Zealand
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Hamilton, , New Zealand
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Havelock North, , New Zealand
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Newtown, , New Zealand
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Papatoetoe, , New Zealand
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Tauranga, , New Zealand
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Cusco, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Miraflores, , Peru
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Piura, , Peru
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Santa Beatriz, , Peru
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Bialystok, , Poland
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Poznan, , Poland
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Ruda Śląska, , Poland
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Rzeszów, , Poland
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Rzeszów, , Poland
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Skarżysko-Kamienna, , Poland
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Szczecin, , Poland
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Tarnów, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Zabrze, , Poland
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Arkhangelsk, , Russia
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Gatchina, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Yekaterinburg, , Russia
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Belgrade, , Serbia
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Belgrade, , Serbia
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Kamenitz, , Serbia
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Kragujevac, , Serbia
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Niš, , Serbia
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Valjevo, , Serbia
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Benoni, , South Africa
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Bloemfontein, , South Africa
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Boksburg, , South Africa
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Cape Town, , South Africa
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Durban, , South Africa
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Durban, , South Africa
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Johannesburg, , South Africa
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Johannesburg, , South Africa
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Port Elizabeth, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Umhlanga, , South Africa
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A Coruña, , Spain
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Alcobendas, , Spain
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Alicante, , Spain
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Alzira, , Spain
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Badalona(Barcelona), , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Cartagena, , Spain
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Girona, , Spain
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Laredo, , Spain
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Lleida, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Marbella (Málaga), , Spain
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Mataró, , Spain
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Málaga, , Spain
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Mérida (Badajoz), , Spain
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Pamplona, , Spain
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Peralada, , Spain
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Ponferrada, , Spain
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Sabadell, , Spain
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Salamanca, , Spain
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Sant Boi de Llobregat, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Helsingborg, , Sweden
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Karlskrona, , Sweden
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Lund, , Sweden
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Malmo, , Sweden
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Stockholm, , Sweden
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Stockholm, , Sweden
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Keelung, , Taiwan
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Belfast, , United Kingdom
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Birmingham, , United Kingdom
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Birmingham, , United Kingdom
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Blackpool, , United Kingdom
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Blackpool, , United Kingdom
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Bradford, , United Kingdom
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Chesterfield, , United Kingdom
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Corby, , United Kingdom
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Edinburgh, , United Kingdom
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Glasgow, , United Kingdom
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Kenilworth, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Middlesex, , United Kingdom
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Norwich, , United Kingdom
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Peterborough, , United Kingdom
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Romford, , United Kingdom
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Shipley, , United Kingdom
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Sidcup, , United Kingdom
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Wokingham, , United Kingdom
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References
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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.
Singh 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.
Rhodes 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.
Rabe 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.
Rabe 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PT010005
Identifier Type: -
Identifier Source: org_study_id
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