Clinical trial NCT00317044: Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
GERD
Keywords: Moderate to severe Asthma
Gastroesophageal Reflux Disease
esomeprazole
GERD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-04-24
Enrollment: 961
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Mean Change in Morning Peak Expiratory Flow (mPEF (L/Minute)) From Baseline (Mean of the Last 7 Days in the run-in Period) to Treatment Period (Mean of All Available Data During the Treatment Period).
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute))
timeFrame: Baseline to 6 months
measure: Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total
timeFrame: Baseline to 6 months
measure: Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Total From Baseline to 6 Months
timeFrame: Baseline to 6 months
measure: Changes in Average Value From Baseline to Treatment Period in Percentage of Nights With Awakening(s) Due to Asthma
timeFrame: Baseline to 6 months
measure: Change in Forced Expiratory Volume in 1 Second (FEV1) From Randomization to Treatment Period.
timeFrame: From randomization (Visit 3) to visit 7.
measure: Number of Patients With Severe Asthma Exacerbations.
timeFrame: Up to 6 months
measure: Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S)) Scores From Randomization (Visit 3) to Visit 7
timeFrame: From randomization (Visit 3) to Visit 7
measure: Change in Symptoms of GERD as Measured by Reflux Disease Questionnaire (RDQ) From Randomization (Visit 3) to Visit 7
timeFrame: Randomization (Visit 3) to Visit 7
measure: Number of Severe Adverse Events
timeFrame: Up to 6 months
measure: Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Night
timeFrame: Baseline to 6 months
measure: Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Day
timeFrame: Baseline to 6 months
measure: Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Night
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Fountain Valley
country: United States
facility: Research Site
state: California
city: Miami
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Stockbridge
country: United States
facility: Research Site
state: Georgia
city: Normal
country: United States
facility: Research Site
state: Illinois
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: Mandeville
country: United States
facility: Research Site
state: Louisiana
city: Wheaton
country: United States
facility: Research Site
state: Maryland
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Papillion
country: United States
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state: Nebraska
city: Asheville
country: United States
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state: North Carolina
city: Cincinnati
country: United States
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state: Ohio
city: Sylvania
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state: Ohio
city: Medford
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state: Oregon
city: Pittsburgh
country: United States
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state: Pennsylvania
city: Upland
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state: Pennsylvania
city: Charleston
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state: South Carolina
city: Austin
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state: Texas
city: Houston
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state: Texas
city: San Antonio
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state: Texas
city: Kirkland
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state: Washington
city: Seattle
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state: Washington
city: Greenfield
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state: Wisconsin
city: Monte Grande
country: Argentina
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state: Buenos Aires
city: Quilmes
country: Argentina
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state: Buenos Aires
city: Córdoba
country: Argentina
facility: Research Site
state: Córdoba, Argentina
city: Rosario
country: Argentina
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state: Santa Fe, Argentina
city: Rosario
country: Argentina
facility: Research Site
state: Santa Fe
city: San Miguel De Tucumán
country: Argentina
facility: Research Site
state: Tucumán, Argentina
city: Buenos Aires
country: Argentina
facility: Research Site
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Research Site
city: Ciudad de Buenos Aires
country: Argentina
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city: Córdoba
country: Argentina
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city: Pleven
country: Bulgaria
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city: Plovdiv
country: Bulgaria
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city: Russe
country: Bulgaria
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city: Sofia
country: Bulgaria
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city: Varna
country: Bulgaria
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city: Calgary
country: Canada
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state: Alberta
city: Bay Roberts
country: Canada
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state: Newfoundland and Labrador
city: Holyrood
country: Canada
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state: Newfoundland and Labrador
city: Brampton
country: Canada
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state: Ontario
city: Hamilton
country: Canada
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state: Ontario
city: Mississauga
country: Canada
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state: Ontario
city: Toronto
country: Canada
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state: Ontario
city: Woodstock
country: Canada
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city: La Malbaie
country: Canada
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state: Quebec
city: Montreal
country: Canada
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state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Benesov U Prahy
country: Czech Republic
facility: Research Site
city: Beroun
country: Czech Republic
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city: Cvikov
country: Czech Republic
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city: Kladno
country: Czech Republic
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city: Kolin 4
country: Czech Republic
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city: Liberec
country: Czech Republic
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city: Praha 10
country: Czech Republic
facility: Research Site
city: Praha 4
country: Czech Republic
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city: Praha 6
country: Czech Republic
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city: Rokycany
country: Czech Republic
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city: Tabor
country: Czech Republic
facility: Research Site
city: Brest
country: France
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city: Ferolles Attilly
country: France
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city: Grasse
country: France
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city: Grenoble
country: France
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city: Marseille Cedex 06
country: France
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country: France
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city: Paris Cedex
country: France
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city: St Laurent Du Var
country: France
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city: Villejuif
country: France
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city: Bad Wörishofen
country: Germany
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city: Berlin
country: Germany
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city: Frankfurt
country: Germany
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city: Freising
country: Germany
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city: Gelnhausen
country: Germany
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city: Gelsenkirchen
country: Germany
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city: Hamburg
country: Germany
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city: Landsberg
country: Germany
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city: Marburg
country: Germany
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city: Nürnberg
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Rodgau-dudenhofen
country: Germany
facility: Research Site
city: Wolmirstedt
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Füzesabony
country: Hungary
facility: Research Site
city: Gyöngyös
country: Hungary
facility: Research Site
city: Győr
country: Hungary
facility: Research Site
city: Hódmezővásárhely
country: Hungary
facility: Research Site
city: Kaposvár
country: Hungary
facility: Research Site
city: Mosonmagyaróvár
country: Hungary
facility: Research Site
city: Szombathely
country: Hungary
facility: Research Site
city: Százhalombatta
country: Hungary
facility: Research Site
city: Cagliari
country: Italy
facility: Research Site
state: CA
city: Crema
country: Italy
facility: Research Site
state: CR
city: Firenze
country: Italy
facility: Research Site
state: FI
city: Arenzano
country: Italy
facility: Research Site
state: GE
city: Palermo
country: Italy
facility: Research Site
state: PA
city: Pisa
country: Italy
facility: Research Site
state: PI
city: Prato
country: Italy
facility: Research Site
state: PO
city: Bussolengo
country: Italy
facility: Research Site
state: VR
city: Verona
country: Italy
facility: Research Site
state: VR
city: Napoli
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Zapopan
country: Mexico
facility: Research Site
state: Jalisco
city: Morelia
country: Mexico
facility: Research Site
state: Michoacan
city: Villahermosa
country: Mexico
facility: Research Site
state: Tabasco
city: Mexico
country: Mexico
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Iława
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Piekary Śląskie
country: Poland
facility: Research Site
city: Skarżysko-Kamienna
country: Poland
facility: Research Site
city: Strzelce Opolskie
country: Poland
facility: Research Site
city: Tarnów
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Amadora
country: Portugal
facility: Research Site
city: Covilhã
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Vila Nova de Gaia
country: Portugal
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Nove Zamky
country: Slovakia
facility: Research Site
city: Nové Zámky
country: Slovakia
facility: Research Site
city: Povazska Bystrica
country: Slovakia
facility: Research Site
city: Prievidza
country: Slovakia
facility: Research Site
city: Rimavska Sobota
country: Slovakia
facility: Research Site
city: Trenčín
country: Slovakia
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
state: Basel Stadt
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Nexium Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.