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)
A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD
1 other identifier
interventional
1,876
19 countries
282
Brief Summary
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2016
282 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
March 30, 2016
CompletedFirst Posted
Study publicly available on registry
April 4, 2016
CompletedStudy Start
First participant enrolled
April 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2018
CompletedResults Posted
Study results publicly available
September 26, 2019
CompletedSeptember 26, 2019
August 1, 2019
1.9 years
March 30, 2016
May 22, 2019
September 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morning Pre-dose Trough FEV1
Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12
at Week 12
Secondary Outcomes (3)
Time to First Moderate or Severe COPD Exacerbation
over 52 weeks
Change From Baseline in Average Daily Rescue Ventolin HFA Use
over 12 weeks
Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in Saint George's Respiratory Questionnaire (SGRQ) Total Score
at Week 12
Study Arms (3)
BFF MDI (PT009) 320/9.6 μg
EXPERIMENTALBudesonide and Formoterol Fumarate Inhalation Aerosol - 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
BFF MDI (PT009) 160/9.6 μg
EXPERIMENTALBudesonide and Formoterol Fumarate Inhalation Aerosol - 80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
FF MDI (PT005) 9.6 μg
EXPERIMENTALFormoterol Fumarate Inhalation Aerosol - 4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Interventions
Blinded Treatment
Blinded Treatment
Blinded Treatment
Eligibility Criteria
You may qualify if:
- Give their signed written informed consent to participate
- At least 40 years of age and no older than 80 years of age
- COPD patients who are symptomatic
- Must be receiving one or more inhaled bronchodilators as maintenance therapy
- Must have a documented history of COPD exacerbations
You may not qualify if:
- Current diagnosis of asthma
- COPD due to α1-Antitrypsin Deficiency
- Known active tuberculosis, lung cancer, cystic fibrosis, and significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months.
- Long-term-oxygen therapy (≥ 15 hours a day).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (282)
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Dothan, Alabama, 36305, United States
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Huntsville, Alabama, 35801, United States
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Sheffield, Alabama, 35660, United States
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Flagstaff, Arizona, 86001, United States
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Costa Mesa, California, 92627, United States
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Gold River, California, 95670, United States
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Lincoln, California, 95648, United States
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Long Beach, California, 90822, United States
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Palo Alto, California, 94304, United States
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San Diego, California, 92103, 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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Upland, California, 91786, United States
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Yorba Linda, California, 92886, United States
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Boulder, Colorado, 80301, United States
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Denver, Colorado, 80246, United States
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New Haven, Connecticut, 06716, United States
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Boynton Beach, Florida, 33472, United States
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Chiefland, Florida, 32626, United States
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Clearwater, Florida, 33765, United States
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Daytona Beach, Florida, 32117, United States
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Hialeah, Florida, 33012, United States
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Kissimmee, Florida, 34741, United States
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Leesburg, Florida, 34748, United States
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Lehigh Acres, Florida, 33971, United States
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Merritt Island, Florida, 32952, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33145, 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, 33173, United States
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Orlando, Florida, 32825, United States
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Ormond Beach, Florida, 32174, United States
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Port Orange, Florida, 32127, United States
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Sarasota, Florida, 34239, 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, 30345, United States
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Dacula, Georgia, 30019, United States
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Decatur, Georgia, 30033, United States
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Snellville, Georgia, 30078, United States
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Stockbridge, Georgia, 30281, United States
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Aurora, Illinois, 60506, United States
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Chicago, Illinois, 60607, United States
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Peoria, Illinois, 61602, United States
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Brownsburg, Indiana, 46112, United States
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Evansville, Indiana, 47714, United States
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Valparaiso, Indiana, 46383, United States
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Iowa City, Iowa, 52242, United States
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Olathe, Kansas, 66061, United States
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Topeka, Kansas, 66604, United States
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Hazard, Kentucky, 41701, United States
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Metairie, Louisiana, 70006, United States
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Sunset, Louisiana, 70584, United States
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Biddeford, Maine, 04005, United States
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Rochester, Minnesota, 55905, United States
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Chesterfield, Missouri, 63017, United States
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Kansas City, Missouri, 64128, United States
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Saint Charles, Missouri, 63301, United States
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St Louis, Missouri, 63122, United States
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Lincoln, Nebraska, 68510, United States
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Reno, Nevada, 89506, United States
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Toms River, New Jersey, 08755, United States
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Brooklyn, New York, 11215, United States
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New York, New York, 10029, United States
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Syracuse, New York, 13210, United States
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The Bronx, New York, 10459, United States
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Gastonia, North Carolina, 28054, United States
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Hickory, North Carolina, 28601, United States
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Hickory, North Carolina, 28602, United States
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Lenoir, North Carolina, 28645, United States
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Tabor City, North Carolina, 28463, United States
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Winston-Salem, North Carolina, 27104, United States
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Canton, Ohio, 44718, United States
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Cincinnati, Ohio, 45242, United States
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Columbus, Ohio, 43207, United States
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Columbus, Ohio, 43213, United States
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Dayton, Ohio, 45417, United States
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Marion, Ohio, 43302, United States
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Wooster, Ohio, 44691, United States
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Edmond, Oklahoma, 73034, United States
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Medford, Oregon, 97504, United States
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Portland, Oregon, 97220, United States
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Johnstown, Pennsylvania, 15905, United States
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Scottdale, Pennsylvania, 15683, United States
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Wyomissing, Pennsylvania, 19610, United States
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Cumberland, Rhode Island, 02864, United States
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East Providence, Rhode Island, 02914, United States
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Warwick, Rhode Island, 02886, United States
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Anderson, South Carolina, 29621, 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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Lancaster, South Carolina, 29720, United States
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Orangeburg, South Carolina, 29118, 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, 29303, United States
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Franklin, Tennessee, 37067, United States
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Knoxville, Tennessee, 37909, United States
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Smyrna, Tennessee, 37167, United States
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Amarillo, Texas, 79106, United States
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Austin, Texas, 78758, United States
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Baytown, Texas, 77521, United States
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Dallas, Texas, 75234, United States
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Houston, Texas, 77030, United States
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Kerrville, Texas, 78028, United States
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Lewisville, Texas, 75067, 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, 75070, United States
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Plano, Texas, 75093, United States
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Port Arthur, Texas, 77640, United States
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Sherman, Texas, 75092, United States
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Spring, Texas, 77379, United States
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Waco, Texas, 76712, United States
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Salt Lake City, Utah, 94102, United States
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Manassas, Virginia, 20110, United States
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Everett, Washington, 98208, United States
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Renton, Washington, 98055, United States
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Milwaukee, Wisconsin, 53226, United States
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Buenos Aires, C1414AIF, Argentina
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CABA, 1426, Argentina
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CABA, C1056ABJ, Argentina
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CABA, C1425BEN, Argentina
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CABA, Argentina
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Ciudad Autonomade Buenos Aires, 1426, Argentina
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Ciudad Autónoma de Buenos Aire, C1440BRR, Argentina
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Ciudad de Buenos Aires, 1425, Argentina
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Concepción del Uruguay, 3260, Argentina
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Córdoba, X5003DCE, Argentina
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Mar del Plata, 7600, Argentina
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Mar del Plata, B7600FZN, Argentina
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Mar del Plata, B7600GNY, Argentina
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Mendoza, 5500, Argentina
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Mendoza, M5500GIP, Argentina
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Nueve de Julio, B6500EZL, Argentina
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Ranelagh, 1886, 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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Bludenz, 6700, Austria
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Feldbach, A-8330, Austria
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Hallein, 5400, Austria
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Linz, 04020, Austria
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Brussels, 1070, Belgium
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Erpent, 5101, Belgium
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Gilly, 6060, Belgium
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Jambes, 5100, Belgium
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Liège, 4000, Belgium
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Roeselare, 8800, Belgium
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Botucatu, 18618-970, Brazil
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Porto Alegre, 90035074, Brazil
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Porto Alegre, 90470-340, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Santo André, 09080-110, Brazil
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São Bernardo do Campo, 09750-420, Brazil
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São Paulo, 01228-200, Brazil
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São Paulo, 04039-901, Brazil
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Sorocaba, 18040-425, Brazil
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Uberlândia, 38411-186, Brazil
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Vitória, 29055-450, Brazil
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Ajax, Ontario, L1S 2J5, Canada
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Windsor, Ontario, N8X 1T3, Canada
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Windsor, Ontario, N8X 5A6, Canada
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Québec, Quebec, G1V 4G5, Canada
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Québec, Quebec, G2J 0C4, Canada
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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
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Trois-Rivières, Quebec, G8T 7A1, Canada
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Curicó, 3341643, Chile
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Santiago, 8380453, Chile
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Santiago, 8380456, Chile
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Talca, 3465584, Chile
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Talcahuano, 4270918, Chile
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Aalborg, 9000, Denmark
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Aarhus N, 8200, Denmark
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Hvidovre, 2650, Denmark
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Kolding, 6000, Denmark
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København NV, 2400, Denmark
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Odense C, 5000, Denmark
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Roskilde, 4000, Denmark
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Silkeborg, 8600, Denmark
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Berlin, 10119, Germany
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Berlin, 12157, Germany
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Berlin, 13187, Germany
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Berlin, 14059, Germany
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Cologne, 51069, Germany
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Cottbus, 03044, Germany
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Frankfurt, 60596, Germany
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Leipzig, 04357, Germany
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Lübeck, 23552, Germany
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Rodgau-Dudenhofen, 63110, Germany
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Bari, 70124, Italy
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Catania, 95123, Italy
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Ferrara, 44121, Italy
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Legnago, 37045, Italy
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Monza, 20900, Italy
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Napoli, 80131, Italy
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Padua, 35128, Italy
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Pavia, 27100, Italy
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Riccione, 47838, Italy
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Rimini, 47921, Italy
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Roma, 00100, Italy
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Roma, 00168, Italy
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Sassari, 07100, Italy
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Durango, 43080, Mexico
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Guadalajara, 44100, Mexico
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Guadalajara, 44130, Mexico
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Guadalajara, 44200, Mexico
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Mexico City, 6760, Mexico
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Minatitlán, 96730, Mexico
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Monterrey, 64460, Mexico
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Sonora, 83000, Mexico
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Villahermosa, 86035, Mexico
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Arendal, 4841, Norway
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Hønefoss, N-3515, Norway
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Kråkeroy, N-1671, Norway
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Stavanger, N-4005, Norway
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Svelvik, 3060, Norway
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Trondheim, 7030, Norway
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Chancay, 15131, Peru
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Cusco, Peru
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Lima, 41, Peru
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Lima, L18, Peru
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Lima, L27, Peru
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Lima, L41, Peru
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Lima, LIMA 1, Peru
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Lima, LIMA 21, Peru
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Lima, LIMA 31, Peru
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Lima, LIMA 32, Peru
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Piura, Peru
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Ponce, 00717, Puerto Rico
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San Juan, 00927, Puerto Rico
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Izhevsk, 426035, Russia
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Moscow, 105077, Russia
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Novosibirsk, 630008, Russia
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Novosibirsk, 630084, Russia
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Omsk, 644043, Russia
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Penza, 440067, Russia
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Perm, 614000, Russia
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Saint Petersburg, 196601, Russia
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Saint Petersburg, 197022, Russia
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StPetersburg, 191180, Russia
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Ulyanovsk, 432009, Russia
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Yekaterinburg, 620039, Russia
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Bloemfontein, 9301, South Africa
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Cape Town, 1730, South Africa
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Cape Town, 7570, South Africa
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Cape Town, 7764, South Africa
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Durban, 4001, South Africa
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Johannesburg, 2001, South Africa
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KwaDukuza, 4450, South Africa
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Lenasia Ext8, 1820, South Africa
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Mowbray, 7700, South Africa
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Parow, South Africa
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Pretoria, 184, South Africa
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Alicante, 03114, Spain
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Alzira (Valencia), 46600, Spain
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Benalmádena (Málaga), 29631, Spain
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Cáceres, 10003, Spain
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Jerez de la Frontera, 11407, Spain
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Laredo, 39770, Spain
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Loja (Granada), 18300, Spain
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Marbella (Málaga), 29603, Spain
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Málaga, 29010, Spain
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Palma de Mallorca, 07010, Spain
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Sagunto(Valencia), 46520, Spain
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Sant Boi de Llobregat, 08830, Spain
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Lund, 221 85, Sweden
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Lund, 222 21, Sweden
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Malmo, 21152, Sweden
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Stockholm, 114 46, Sweden
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Uppsala, 75237, Sweden
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Bradford, BD9 6RJ, United Kingdom
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Chertsey, KT16 0PZ, United Kingdom
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Chester, CH2 1UL, United Kingdom
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Doncaster, DN2 5LT, United Kingdom
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Lancaster, LA1 4RP, United Kingdom
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Sheffield, S5 7AU, United Kingdom
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Wishaw, ML2 0DP, United Kingdom
Related Publications (1)
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.
PMID: 35815359DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Paul M. Dorinsky, MD
- Organization
- Pearl Therapeutics, a Member of the AstraZeneca Group
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
March 30, 2016
First Posted
April 4, 2016
Study Start
April 29, 2016
Primary Completion
April 4, 2018
Study Completion
April 4, 2018
Last Updated
September 26, 2019
Results First Posted
September 26, 2019
Record last verified: 2019-08