Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma (RELAX)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00317044
First received: April 20, 2006
Last updated: March 11, 2009
Last verified: March 2009
  Purpose

The purpose of this study is to determine whether treatment with esomeprazole for 6 months will improve asthma in adult patients with moderate to severe asthma and symptoms of gastroesophageal reflux disease.


Condition Intervention Phase
Asthma
GERD
Drug: Esomeprazole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 6-Month Randomized, Double-Blind, Parallel-Group, Multicentre, Placebo-Controlled Phase II Study to Compare Anti-Asthmatic Effect and Safety of Esomeprazole (Nexium®) 40 mg Twice Daily or 40 mg Once Daily With Placebo in Adults With Asthma

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Primary objective is to compare the anti-asthmatic effect of esomeprazole with that of placebo in adult asthmatics with gastroesophageal reflux by evaluating change in morning Peak Expiratory Flow from baseline (run-in) to treatment period.

Secondary Outcome Measures:
  • Secondary objectives are to investigate the effect on symptoms of GERD as measured by Reflux Disease Questionnaire from randomization to end of study and to assess safety and tolerability by AEs, laboratory tests, physical examination, and vital signs.

Estimated Enrollment: 1100
Study Start Date: April 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with diagnosis of asthma since at least 6 months.
  • 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 clinically relevant abnormalities.
  • Patients with a smoking history of ≥10 pack-year.
  • Patients who have had previous surgery on the esophagus or the stomach.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00317044

  Hide Study Locations
Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, Arizona
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Scottsdale, Arizona, United States
United States, Arkansas
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Little Rock, Arkansas, United States
United States, California
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Fountain Valley, California, United States
United States, Florida
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Miami, Florida, United States
United States, Georgia
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Atlanta, Georgia, United States
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Stockbridge, Georgia, United States
United States, Illinois
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Normal, Illinois, United States
United States, Kansas
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Overland Park, Kansas, United States
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Wichita, Kansas, United States
United States, Louisiana
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Mandeville, Louisiana, United States
United States, Maryland
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Wheaton, Maryland, United States
United States, Missouri
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St. Louis, Missouri, United States
United States, Nebraska
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Papillion, Nebraska, United States
United States, North Carolina
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Asheville, North Carolina, United States
United States, Ohio
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Cincinnati, Ohio, United States
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Sylvania, Ohio, United States
United States, Oregon
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Medford, Oregon, United States
United States, Pennsylvania
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Pittsburgh, Pennsylvania, United States
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Upland, Pennsylvania, United States
United States, South Carolina
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Charleston, South Carolina, United States
United States, Texas
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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
United States, Washington
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Kirkland, Washington, United States
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Seattle, Washington, United States
United States, Wisconsin
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Greenfield, Wisconsin, United States
Argentina
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Monte Grande, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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C�rdoba, C�rdoba, Argentina, Argentina
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Rosario, Santa Fe, Argentina, Argentina
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Rosario, Santa Fe, Argentina
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San Miguel de Tucum�n, Tucum�n, Argentina, Argentina
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Buenos Aires, Argentina
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Ciudad Aut�noma de Bs. As., Argentina
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Ciudad de Buenos Aires, Argentina
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C�rdoba, Argentina
Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Russe, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
Canada, Alberta
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Calgary, Alberta, Canada
Canada, Newfoundland and Labrador
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Bay Roberts, Newfoundland and Labrador, Canada
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Holyrood, Newfoundland and Labrador, Canada
Canada, Ontario
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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
Canada
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Quebec, Canada
Czech Republic
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Benesov U Prahy, Czech Republic
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Beroun, Czech Republic
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Cvikov, Czech Republic
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Kladno, Czech Republic
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Kolin 4, Czech Republic
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Liberec, Czech Republic
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Praha 10, Czech Republic
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Praha 4, Czech Republic
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Praha 6, Czech Republic
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Rokycany, Czech Republic
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Tabor, Czech Republic
France
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Brest, France
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Ferolles Attilly, France
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Grasse, France
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Grenoble, France
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Marseille Cedex 06, France
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Montpellier, France
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Paris Cedex, France
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St Laurent Du Var, France
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Villejuif, France
Germany
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Bad W�rishofen, 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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N�rnberg, Germany
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Potsdam, Germany
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Rodgau-dudenhofen, Germany
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Wolmirstedt, Germany
Hungary
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Budapest, Hungary
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F�zesabony, Hungary
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Gy�ngy�s, Hungary
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Gy�r, Hungary
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H�dmez�v�s�rhely, Hungary
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Kapuv�r, Hungary
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Mosonmagyar�v�r, Hungary
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Szombathely, Hungary
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Sz�zhalombatta, Hungary
Italy
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Cagliari, CA, Italy
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Crema, CR, Italy
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Firenze, 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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Bussolengo, VR, Italy
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Verona, VR, Italy
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Napoli, Italy
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Roma, Italy
Mexico
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Guadalajara, Jalisco, Mexico
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Zapopan, Jalisco, Mexico
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Morelia, Michoacan, Mexico
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Villahermosa, Tabasco, Mexico
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Mexico, Mexico
Poland
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Bydgoszcz, Poland
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Gdynia, Poland
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I�awa, Poland
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Krak�w, Poland
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Piekary �l�skie, Poland
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Skar�ysko Kamienna, Poland
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Strzelce Opolskie, Poland
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Tarn�w, Poland
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Zabrze, Poland
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��d�, Poland
Portugal
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Amadora, Portugal
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Covilh�, Portugal
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Porto, Portugal
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Vila Nova de Gaia, Portugal
Slovakia
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Bratislava, Slovakia
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Kosice, Slovakia
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Nove Zamky, Slovakia
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Nov� Zamky, Slovakia
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Povazska Bystrica, Slovakia
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Prievidza, Slovakia
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Rimavska Sobota, Slovakia
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Tren��n, Slovakia
Switzerland
Research Site
Basel, Basel Stadt, Switzerland
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Nexium Medical Science Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00317044     History of Changes
Other Study ID Numbers: D9618C00001, RELAX
Study First Received: April 20, 2006
Last Updated: March 11, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Moderate to severe Asthma
Gastroesophageal Reflux Disease
esomeprazole
GERD

Additional relevant MeSH terms:
Asthma
Gastroesophageal Reflux
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Asthmatic Agents
Omeprazole
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014