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)
NCT ID: NCT02727660
Last Updated: 2019-09-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1876 participants
INTERVENTIONAL
2016-04-29
2018-04-04
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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BFF MDI (PT009) 320/9.6 μg
Budesonide and Formoterol Fumarate Inhalation Aerosol - 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
BFF MDI (PT009) 320/9.6 μg
Blinded Treatment
BFF MDI (PT009) 160/9.6 μg
Budesonide and Formoterol Fumarate Inhalation Aerosol - 80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
BFF MDI (PT009) 160/9.6 μg
Blinded Treatment
FF MDI (PT005) 9.6 μg
Formoterol Fumarate Inhalation Aerosol - 4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
FF MDI (PT005) 9.6 μg
Blinded Treatment
Interventions
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BFF MDI (PT009) 320/9.6 μg
Blinded Treatment
BFF MDI (PT009) 160/9.6 μg
Blinded Treatment
FF MDI (PT005) 9.6 μg
Blinded Treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
40 Years
80 Years
ALL
No
Sponsors
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Pearl Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Dothan, Alabama, United States
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Huntsville, Alabama, United States
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Sheffield, Alabama, United States
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Flagstaff, Arizona, United States
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Costa Mesa, California, United States
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Gold River, California, United States
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Lincoln, California, United States
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Long Beach, California, United States
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Palo Alto, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Upland, California, United States
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Yorba Linda, California, United States
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Boulder, Colorado, United States
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Denver, Colorado, United States
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New Haven, Connecticut, United States
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Boynton Beach, Florida, United States
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Chiefland, Florida, United States
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Clearwater, Florida, United States
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Daytona Beach, Florida, United States
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Hialeah, Florida, United States
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Kissimmee, Florida, United States
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Leesburg, Florida, United States
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Lehigh Acres, Florida, United States
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Merritt Island, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
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Port Orange, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Dacula, Georgia, United States
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Decatur, Georgia, United States
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Snellville, Georgia, United States
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Stockbridge, Georgia, United States
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Aurora, Illinois, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Brownsburg, Indiana, United States
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Evansville, Indiana, United States
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Valparaiso, Indiana, United States
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Iowa City, Iowa, United States
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Olathe, Kansas, United States
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Topeka, Kansas, United States
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Hazard, Kentucky, United States
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Metairie, Louisiana, United States
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Sunset, Louisiana, United States
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Biddeford, Maine, United States
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Rochester, Minnesota, United States
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Chesterfield, Missouri, United States
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Kansas City, Missouri, United States
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Saint Charles, Missouri, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Reno, Nevada, United States
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Toms River, New Jersey, United States
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Brooklyn, New York, United States
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New York, New York, United States
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Syracuse, New York, United States
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The Bronx, New York, United States
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Gastonia, North Carolina, United States
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Hickory, North Carolina, United States
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Hickory, North Carolina, United States
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Lenoir, North Carolina, United States
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Tabor City, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Marion, Ohio, United States
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Wooster, Ohio, United States
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Edmond, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Johnstown, Pennsylvania, United States
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Scottdale, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Cumberland, Rhode Island, United States
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East Providence, Rhode Island, United States
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Warwick, Rhode Island, United States
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Anderson, 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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Lancaster, South Carolina, United States
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Orangeburg, 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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Franklin, Tennessee, United States
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Knoxville, Tennessee, United States
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Smyrna, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Baytown, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Kerrville, Texas, United States
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Lewisville, 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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Plano, Texas, United States
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Port Arthur, Texas, United States
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Sherman, Texas, United States
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Spring, Texas, United States
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Waco, Texas, United States
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Salt Lake City, Utah, United States
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Manassas, Virginia, United States
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Everett, Washington, United States
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Renton, Washington, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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Ciudad Autonomade Buenos Aires, , Argentina
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Ciudad Autónoma de Buenos Aire, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Concepción del Uruguay, , Argentina
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Córdoba, , Argentina
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Mar del Plata, , Argentina
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Mar del Plata, , Argentina
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Mar del Plata, , Argentina
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Mendoza, , Argentina
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Mendoza, , Argentina
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Nueve de Julio, , Argentina
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Ranelagh, , Argentina
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Rosario, , Argentina
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San Fernando, , Argentina
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San Juan Bautista, , Argentina
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San Miguel de Tucumán, , Argentina
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Bludenz, , Austria
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Feldbach, , Austria
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Hallein, , Austria
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Linz, , Austria
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Brussels, , Belgium
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Erpent, , Belgium
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Gilly, , Belgium
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Jambes, , Belgium
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Liège, , Belgium
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Roeselare, , Belgium
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Botucatu, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Santo André, , Brazil
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São Bernardo do Campo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Sorocaba, , Brazil
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Uberlândia, , Brazil
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Vitória, , Brazil
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Ajax, Ontario, Canada
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Windsor, Ontario, Canada
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Windsor, Ontario, 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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Trois-Rivières, Quebec, Canada
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Curicó, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Talca, , Chile
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Talcahuano, , Chile
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Aalborg, , Denmark
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Aarhus N, , Denmark
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Hvidovre, , Denmark
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Kolding, , Denmark
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København NV, , Denmark
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Odense C, , Denmark
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Roskilde, , Denmark
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Silkeborg, , Denmark
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Cottbus, , Germany
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Frankfurt, , Germany
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Leipzig, , Germany
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Lübeck, , Germany
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Rodgau-Dudenhofen, , Germany
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Bari, , Italy
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Catania, , Italy
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Ferrara, , Italy
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Legnago, , Italy
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Monza, , Italy
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Napoli, , Italy
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Padua, , Italy
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Pavia, , Italy
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Riccione, , Italy
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Rimini, , Italy
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Roma, , Italy
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Roma, , Italy
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Sassari, , Italy
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Durango, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Mexico City, , Mexico
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Minatitlán, , Mexico
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Monterrey, , Mexico
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Sonora, , Mexico
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Villahermosa, , Mexico
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Arendal, , Norway
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Hønefoss, , Norway
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Kråkeroy, , Norway
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Stavanger, , Norway
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Svelvik, , Norway
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Trondheim, , Norway
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Chancay, , Peru
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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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Piura, , Peru
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Ponce, , Puerto Rico
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San Juan, , Puerto Rico
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Izhevsk, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Novosibirsk, , Russia
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Omsk, , Russia
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Penza, , Russia
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Perm, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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StPetersburg, , Russia
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Ulyanovsk, , Russia
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Yekaterinburg, , Russia
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Bloemfontein, , South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Durban, , South Africa
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Johannesburg, , South Africa
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KwaDukuza, , South Africa
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Lenasia Ext8, , South Africa
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Mowbray, , South Africa
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Parow, , South Africa
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Pretoria, , South Africa
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Alicante, , Spain
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Alzira (Valencia), , Spain
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Benalmádena (Málaga), , Spain
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Cáceres, , Spain
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Jerez de la Frontera, , Spain
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Laredo, , Spain
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Loja (Granada), , Spain
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Marbella (Málaga), , Spain
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Málaga, , Spain
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Palma de Mallorca, , Spain
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Sagunto(Valencia), , Spain
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Sant Boi de Llobregat, , Spain
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Lund, , Sweden
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Lund, , Sweden
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Malmo, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Bradford, , United Kingdom
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Chertsey, , United Kingdom
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Chester, , United Kingdom
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Doncaster, , United Kingdom
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Lancaster, , United Kingdom
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Sheffield, , United Kingdom
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Wishaw, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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PT009003
Identifier Type: -
Identifier Source: org_study_id
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