A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD
NCT ID: NCT00419744
Last Updated: 2010-09-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
1200 participants
INTERVENTIONAL
2007-01-31
2009-08-31
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
DOUBLE
Interventions
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Budesonide/formoterol (SYMBICORT) pMDI
Formoterol Turbuhaler
Eligibility Criteria
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Inclusion Criteria
* Current smoker or smoking history of 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year)
* A history of at least 1 COPD exacerbations requiring a course of steroids and/or antibiotics within 1-12 months before the first visit
Exclusion Criteria
* A history of allergic rhinitis at or after 18 years of age
* Subjects taking oral steroids
* Any significant disease or disorder that may jeopardize a subject's safety
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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Christer Hultquist, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Jasper, Alabama, United States
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Mobile, Alabama, United States
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Tucson, Arizona, United States
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Fort Smith, Arkansas, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Foothill Ranch, California, United States
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Fullerton, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Banos, California, United States
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Mission Viejo, California, United States
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Pismo Beach, California, United States
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Rancho Cordova, 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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San Diego, California, United States
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Sepulveda, California, United States
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Torrance, California, United States
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Englewood, Colorado, United States
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Wheat Ridge, Colorado, United States
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Stanford, Connecticut, United States
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DeLand, Florida, United States
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Opa-locka, Florida, United States
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Orange City, Florida, United States
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Orlando, Florida, United States
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Panama City, Florida, United States
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Pensacola, Florida, United States
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Saint Cloud, Florida, United States
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Sarasota, Florida, United States
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Augusta, Georgia, United States
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Blue Ridge, Georgia, United States
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Marietta, Georgia, United States
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Boise, Idaho, United States
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Coeur d'Alene, Idaho, United States
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Chicago, Illinois, United States
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Council Bluffs, Iowa, United States
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Witchita, Kansas, United States
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Marrero, Louisiana, United States
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Metairie, Louisiana, United States
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Sunset, Louisiana, United States
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Bangor, Maine, United States
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Pittsfield, Massachusetts, United States
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Waltham, Massachusetts, United States
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Chesterfield, Missouri, United States
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Florissant, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Missoula, Montana, United States
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Omaha, Nebraska, United States
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Papillion, Nebraska, United States
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Las Vegas, Nevada, United States
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Springfield, New Jersey, United States
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Bronxville, New York, United States
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Elmira, New York, United States
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Larchmont, New York, United States
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Charlotte, North Carolina, United States
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Elizabeth City, North Carolina, United States
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Hickory, North Carolina, United States
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Chardon, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Sylvania, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Beaver, Pennsylvania, United States
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Bensalem, Pennsylvania, United States
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Downingtown, Pennsylvania, United States
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Harrisburg, Pennsylvania, United States
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Landsdale, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Warminster, Pennsylvania, United States
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Yardley, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Charleston, 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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Prosperity, 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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Fayetteville, Tennessee, United States
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Boerne, Texas, United States
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Houston, Texas, United States
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McKinney, Texas, United States
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San Antonio, Texas, United States
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Abingdon, Virginia, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Capital Federal, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Nueve de Julio, Buenos Aires, Argentina
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Ramos Mejía, Buenos Aires, Argentina
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Vicente López, Buenos Aires, Argentina
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Corrientes, Corrientes Province, Argentina
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Córdoba, Córdoba Province, Argentina
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Mendoza, Mendoza Province, Argentina
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San Juan, San Juan Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Fortaleza, Ceará, Brazil
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Goiânia, Goiás, Brazil
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Curitiba, Paraná, Brazil
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Recife, Pernambuco, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porta Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Florian�polis, Santa Catarina, Brazil
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Santo André, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Valparaíso, Región de Valparaíso, Chile
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Rancagua, Región del Libertador General Bernardo O’Higgins, Chile
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Santiago, RM, Chile
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Medillin, Antioquia, Colombia
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Barranquilla, Atl�ntico, Colombia
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Bogota Dc, Cundianmarca, Colombia
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Guadalajara, Jalisco, Mexico
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Lima, Lima Province, Peru
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Jesus Maria, Lima region, Peru
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San Borja, Lima region, Peru
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Surco, Lima region, Peru
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Belvilee, Cape Town, South Africa
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Tygerberg, Cape Town, South Africa
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Port Elizabeth, E Cape, South Africa
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Korsten, Port Elizabeth, South Africa
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Groenkloof, Pretoria, South Africa
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Thaba Tswane, Pretoria, South Africa
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Cape Town, South Africa, South Africa
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Durban, South Africa, South Africa
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Bloemfontein, , South Africa
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Boksburg, , South Africa
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Centurion, , South Africa
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eManzimtoti, , South Africa
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Humansdorp, , South Africa
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Pretoria, , South Africa
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Pretoria West, , South Africa
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Roodepoort, , South Africa
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Distrito Capital, Miranda, Venezuela
Countries
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References
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Bafadhel M, Peterson S, De Blas MA, Calverley PM, Rennard SI, Richter K, Fageras M. Predictors of exacerbation risk and response to budesonide in patients with chronic obstructive pulmonary disease: a post-hoc analysis of three randomised trials. Lancet Respir Med. 2018 Feb;6(2):117-126. doi: 10.1016/S2213-2600(18)30006-7. Epub 2018 Jan 10.
Jenkins CR, Postma DS, Anzueto AR, Make BJ, Peterson S, Eriksson G, Calverley PM. Reliever salbutamol use as a measure of exacerbation risk in chronic obstructive pulmonary disease. BMC Pulm Med. 2015 Aug 21;15:97. doi: 10.1186/s12890-015-0077-0.
Make BJ, Eriksson G, Calverley PM, Jenkins CR, Postma DS, Peterson S, Ostlund O, Anzueto A. A score to predict short-term risk of COPD exacerbations (SCOPEX). Int J Chron Obstruct Pulmon Dis. 2015 Jan 27;10:201-9. doi: 10.2147/COPD.S69589. eCollection 2015.
Sharafkhaneh A, Southard JG, Goldman M, Uryniak T, Martin UJ. Effect of budesonide/formoterol pMDI on COPD exacerbations: a double-blind, randomized study. Respir Med. 2012 Feb;106(2):257-68. doi: 10.1016/j.rmed.2011.07.020. Epub 2011 Oct 26.
Other Identifiers
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D589CC00003
Identifier Type: -
Identifier Source: org_study_id