Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma
NCT ID: NCT00317044
Last Updated: 2014-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
961 participants
INTERVENTIONAL
2006-04-30
2008-07-31
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
QUADRUPLE
Study Groups
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Esomeprazole 40 mg twice daily
Esomeprazole
Esomeprazole 40 mg twice daily
Esomeprazole 40 mg once daily
Esomeprazole
Esomeprazole 40 mg once daily
Placebo
Placebo
Placebo twice daily
Interventions
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Esomeprazole
Esomeprazole 40 mg twice daily
Esomeprazole
Esomeprazole 40 mg once daily
Placebo
Placebo twice daily
Eligibility Criteria
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Inclusion Criteria
* Symptoms of asthma during run-in.
* At least 3 months history and present symptoms of 1 or more of the following: burning feeling behind breastbone, pain behind breastbone, acid taste in the mouth.
Exclusion Criteria
* Patients with a smoking history of ≥10 pack-year.
* Patients who have had previous surgery on the esophagus or the stomach.
18 Years
70 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca Nexium Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Birmingham, Alabama, United States
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Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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Fountain Valley, California, United States
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Miami, Florida, United States
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Atlanta, Georgia, United States
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Stockbridge, Georgia, United States
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Normal, Illinois, United States
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Overland Park, Kansas, United States
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Wichita, Kansas, United States
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Mandeville, Louisiana, United States
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Wheaton, Maryland, United States
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St Louis, Missouri, United States
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Papillion, Nebraska, United States
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Asheville, North Carolina, United States
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Cincinnati, Ohio, United States
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Sylvania, Ohio, United States
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Medford, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Upland, Pennsylvania, United States
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Charleston, South Carolina, United States
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Austin, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Kirkland, Washington, United States
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Seattle, Washington, United States
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Greenfield, Wisconsin, United States
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Ciudad de Buenos Aires, Argentina, Argentina
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Monte Grande, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Córdoba, Córdoba, Argentina, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe, Argentina, Argentina
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San Miguel de Tucumán, Tucumán, Argentina, Argentina
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Buenos Aires, , Argentina
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Calgary, Alberta, Canada
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Bay Roberts, Newfoundland and Labrador, Canada
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Holyrood, Newfoundland and Labrador, Canada
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Brampton, Ontario, Canada
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Hamilton, Ontario, Canada
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Mississauga, Ontario, Canada
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Toronto, Ontario, Canada
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Woodstock, Ontario, Canada
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La Malbaie, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Benesov U Prahy, , Czechia
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Beroun, , Czechia
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Cvikov, , Czechia
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Kladno, , Czechia
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Kolín, , Czechia
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Liberec, , Czechia
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Prague, , Czechia
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Rokycany, , Czechia
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Tábor, , Czechia
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Brest, , France
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Férolles-Attilly, , France
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Grasse, , France
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Grenoble, , France
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Marseille, , France
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Montpellier, , France
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Paris, , France
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Saint-Laurent-du-Var, , France
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Villejuif, , France
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Bad Wörishofen, , Germany
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Berlin, , Germany
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Frankfurt, , Germany
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Freising, , Germany
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Gelnhausen, , Germany
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Gelsenkirchen, , Germany
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Hamburg, , Germany
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Landsberg, , Germany
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Marburg, , Germany
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Nuremberg, , Germany
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Potsdam, , Germany
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Rodgau-dudenhofen, , Germany
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Wolmirstedt, , Germany
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Budapest, , Hungary
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Füzesabony, , Hungary
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Gyöngyös, , Hungary
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Győr, , Hungary
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Hódmezővásárhely, , Hungary
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Kaposvár, , Hungary
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Mosonmagyaróvár, , Hungary
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Százhalombatta, , Hungary
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Szombathely, , Hungary
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Cagliari, CA, Italy
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Crema, CR, Italy
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Florence, FI, Italy
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Arenzano, GE, Italy
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Palermo, PA, Italy
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Pisa, PI, Italy
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Prato, PO, Italy
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Roma, Roma, Italy
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Bussolengo, VR, Italy
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Verona, VR, Italy
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Napoli, , Italy
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Guadalajara, Jalisco, Mexico
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Zapopan, Jalisco, Mexico
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Morelia, Michoacán, Mexico
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Villahermosa, Tabasco, Mexico
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México, , Mexico
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Bydgoszcz, , Poland
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Gdynia, , Poland
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Iława, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Piekary Śląskie, , Poland
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Skarżysko-Kamienna, , Poland
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Strzelce Opolskie, , Poland
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Tarnów, , Poland
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Zabrze, , Poland
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Amadora, , Portugal
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Covilha, , Portugal
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Porto, , Portugal
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Vila Nova de Gaia, , Portugal
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Bratislava, , Slovakia
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Košice, , Slovakia
Research Site
Nové Zámky, , Slovakia
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Považská Bystrica, , Slovakia
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Prievidza, , Slovakia
Research Site
Rimavská Sobota, , Slovakia
Research Site
Trenčín, , Slovakia
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Basel, Canton of Basel-City, Switzerland
Countries
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References
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Kiljander TO, Junghard O, Beckman O, Lind T. Effect of esomeprazole 40 mg once or twice daily on asthma: a randomized, placebo-controlled study. Am J Respir Crit Care Med. 2010 May 15;181(10):1042-8. doi: 10.1164/rccm.200910-1537OC. Epub 2010 Jan 28.
Related Links
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Other Identifiers
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RELAX
Identifier Type: -
Identifier Source: secondary_id
D9618C00001
Identifier Type: -
Identifier Source: org_study_id
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