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

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

961 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma GERD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Esomeprazole 40 mg twice daily

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

Esomeprazole 40 mg twice daily

Esomeprazole 40 mg once daily

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

Esomeprazole 40 mg once daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo twice daily

Interventions

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Esomeprazole

Esomeprazole 40 mg twice daily

Intervention Type DRUG

Esomeprazole

Esomeprazole 40 mg once daily

Intervention Type DRUG

Placebo

Placebo twice daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

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Nové Zámky, , Slovakia

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Považská Bystrica, , Slovakia

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Prievidza, , Slovakia

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Rimavská Sobota, , Slovakia

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Trenčín, , Slovakia

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Basel, Canton of Basel-City, Switzerland

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Countries

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United States Argentina Bulgaria Canada Czechia France Germany Hungary Italy Mexico Poland Portugal Slovakia Switzerland

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.

Reference Type DERIVED
PMID: 20110554 (View on PubMed)

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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