Back to resultsSafety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma (RELAX)
Primary Purpose
Asthma, GERD
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Esomeprazole
Esomeprazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Moderate to severe Asthma, Gastroesophageal Reflux Disease, esomeprazole, GERD
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Esomeprazole 40 mg twice daily
Esomeprazole 40 mg once daily
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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).
Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. Results presented as a mean of all available data during the treatment period.
Secondary Outcome Measures
Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute))
Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. No dispersion measure available.
Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total
Participants must have both baseline and flow up measure to be included in analysis. Each morning and evening, the patient will be asked to record his/her asthma symptoms (sx) in the diary. The asthma sx scores during night- and daytime will be assessed by the patient according to the following scoring system: 0 = no asthma sx; 1 = you are aware of your asthma sx but can easily tolerate the sx; 2 = your asthma sx are causing you enough discomfort to cause problems with normal activities (or with sleep); 3 = you are unable to do your normal activities (or sleep) because of your asthma. The total symptom score is the sum of the night- and daytime scores.
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
This is the change in the average number of inhalations from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis. Treatment mean calculated using the entire treatment period.
Changes in Average Value From Baseline to Treatment Period in Percentage of Nights With Awakening(s) Due to Asthma
Change in percentage of nights with night-time awakening(s) due to asthma from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis.
Change in Forced Expiratory Volume in 1 Second (FEV1) From Randomization to Treatment Period.
Description: Changes in forced expiratory volume in 1 second (FEV1) from randomization (Visit 3) to the treatment period considered as mean value at Visits 4-7. Participants must have both baseline and follow up measure to be included in analysis.
Number of Patients With Severe Asthma Exacerbations.
Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S)) Scores From Randomization (Visit 3) to Visit 7
The Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S))has been developed by and includes 32 questions in 4 domains: activity limitation, symptoms, emotional function, and exposure to environmental stimuli. It is used to measure the physical and emotional impact of the disease in the selected areas of life. Participants must have both baseline and follow up measure to be included in analysis.AQLQ(S) score based on a 7-point scale that ranged from 1 (worst quality of life) to 7 (best quality of life).
Change in Symptoms of GERD as Measured by Reflux Disease Questionnaire (RDQ) From Randomization (Visit 3) to Visit 7
The RDQ questionnaire is used to assess six GI symptoms during the previous week (a burning feeling behind the breastbone, pain behind the breastbone, a burning feeling in the centre of the stomach, pain in the centre of the stomach, an acid taste in the mouth, unpleasant movement of material upwards from the stomach). Each symptom is given a frequency score on a six-point scale (from 0=did not have to 5=daily) and an intensity score on a six-point scale (from 0=did not have to 5=severe). Three domain scores are calculated by forming averages of the frequency and intensity scores of selected symptoms (heartburn: the first two symptoms; dyspepsia: the next two symptoms; regurgitation: the last two symptoms). The overall GERD score is calculated as the average of the hearburn and dyspepsia domain scores. The GERD score can thus range from 0 to 5.
Number of Severe Adverse Events
Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Night
Participants must have both baseline and follow up measure to be included in analysis
Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Day
Participants must have both baseline and follow up measure to be included in analysis
Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Night
Participants must have both baseline and follow up measure to be included in analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00317044
Brief Title
Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma
Acronym
RELAX
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
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, GERD
Keywords
Moderate to severe Asthma, Gastroesophageal Reflux Disease, esomeprazole, GERD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
961 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Esomeprazole 40 mg twice daily
Arm Type
Experimental
Arm Title
Esomeprazole 40 mg once daily
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
Esomeprazole 40 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
Esomeprazole 40 mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo twice daily
Primary Outcome Measure Information:
Title
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).
Description
Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. Results presented as a mean of all available data during the treatment period.
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute))
Description
Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. No dispersion measure available.
Time Frame
Baseline to 6 months
Title
Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total
Description
Participants must have both baseline and flow up measure to be included in analysis. Each morning and evening, the patient will be asked to record his/her asthma symptoms (sx) in the diary. The asthma sx scores during night- and daytime will be assessed by the patient according to the following scoring system: 0 = no asthma sx; 1 = you are aware of your asthma sx but can easily tolerate the sx; 2 = your asthma sx are causing you enough discomfort to cause problems with normal activities (or with sleep); 3 = you are unable to do your normal activities (or sleep) because of your asthma. The total symptom score is the sum of the night- and daytime scores.
Time Frame
Baseline to 6 months
Title
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
Description
This is the change in the average number of inhalations from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis. Treatment mean calculated using the entire treatment period.
Time Frame
Baseline to 6 months
Title
Changes in Average Value From Baseline to Treatment Period in Percentage of Nights With Awakening(s) Due to Asthma
Description
Change in percentage of nights with night-time awakening(s) due to asthma from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis.
Time Frame
Baseline to 6 months
Title
Change in Forced Expiratory Volume in 1 Second (FEV1) From Randomization to Treatment Period.
Description
Description: Changes in forced expiratory volume in 1 second (FEV1) from randomization (Visit 3) to the treatment period considered as mean value at Visits 4-7. Participants must have both baseline and follow up measure to be included in analysis.
Time Frame
From randomization (Visit 3) to visit 7.
Title
Number of Patients With Severe Asthma Exacerbations.
Time Frame
Up to 6 months
Title
Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S)) Scores From Randomization (Visit 3) to Visit 7
Description
The Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S))has been developed by and includes 32 questions in 4 domains: activity limitation, symptoms, emotional function, and exposure to environmental stimuli. It is used to measure the physical and emotional impact of the disease in the selected areas of life. Participants must have both baseline and follow up measure to be included in analysis.AQLQ(S) score based on a 7-point scale that ranged from 1 (worst quality of life) to 7 (best quality of life).
Time Frame
From randomization (Visit 3) to Visit 7
Title
Change in Symptoms of GERD as Measured by Reflux Disease Questionnaire (RDQ) From Randomization (Visit 3) to Visit 7
Description
The RDQ questionnaire is used to assess six GI symptoms during the previous week (a burning feeling behind the breastbone, pain behind the breastbone, a burning feeling in the centre of the stomach, pain in the centre of the stomach, an acid taste in the mouth, unpleasant movement of material upwards from the stomach). Each symptom is given a frequency score on a six-point scale (from 0=did not have to 5=daily) and an intensity score on a six-point scale (from 0=did not have to 5=severe). Three domain scores are calculated by forming averages of the frequency and intensity scores of selected symptoms (heartburn: the first two symptoms; dyspepsia: the next two symptoms; regurgitation: the last two symptoms). The overall GERD score is calculated as the average of the hearburn and dyspepsia domain scores. The GERD score can thus range from 0 to 5.
Time Frame
Randomization (Visit 3) to Visit 7
Title
Number of Severe Adverse Events
Time Frame
Up to 6 months
Title
Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Night
Description
Participants must have both baseline and follow up measure to be included in analysis
Time Frame
Baseline to 6 months
Title
Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Day
Description
Participants must have both baseline and follow up measure to be included in analysis
Time Frame
Baseline to 6 months
Title
Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Night
Description
Participants must have both baseline and follow up measure to be included in analysis
Time Frame
Baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Nexium Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Scottsdale
State/Province
Arizona
Country
United States
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City
Little Rock
State/Province
Arkansas
Country
United States
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City
Fountain Valley
State/Province
California
Country
United States
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City
Miami
State/Province
Florida
Country
United States
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City
Atlanta
State/Province
Georgia
Country
United States
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City
Stockbridge
State/Province
Georgia
Country
United States
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City
Normal
State/Province
Illinois
Country
United States
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City
Overland Park
State/Province
Kansas
Country
United States
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City
Wichita
State/Province
Kansas
Country
United States
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City
Mandeville
State/Province
Louisiana
Country
United States
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City
Wheaton
State/Province
Maryland
Country
United States
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City
St. Louis
State/Province
Missouri
Country
United States
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City
Papillion
State/Province
Nebraska
Country
United States
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City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
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City
Sylvania
State/Province
Ohio
Country
United States
Facility Name
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City
Medford
State/Province
Oregon
Country
United States
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City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
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City
Upland
State/Province
Pennsylvania
Country
United States
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City
Charleston
State/Province
South Carolina
Country
United States
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City
Austin
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
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City
San Antonio
State/Province
Texas
Country
United States
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Research Site
City
Kirkland
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Greenfield
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Monte Grande
State/Province
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Quilmes
State/Province
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Córdoba
State/Province
Córdoba, Argentina
Country
Argentina
Facility Name
Research Site
City
Rosario
State/Province
Santa Fe, Argentina
Country
Argentina
Facility Name
Research Site
City
Rosario
State/Province
Santa Fe
Country
Argentina
Facility Name
Research Site
City
San Miguel De Tucumán
State/Province
Tucumán, Argentina
Country
Argentina
Facility Name
Research Site
City
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Ciudad Autónoma de Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Ciudad de Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Córdoba
Country
Argentina
Facility Name
Research Site
City
Pleven
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
Country
Bulgaria
Facility Name
Research Site
City
Russe
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Varna
Country
Bulgaria
Facility Name
Research Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Bay Roberts
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Research Site
City
Holyrood
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Research Site
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Woodstock
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
La Malbaie
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Quebec
Country
Canada
Facility Name
Research Site
City
Benesov U Prahy
Country
Czech Republic
Facility Name
Research Site
City
Beroun
Country
Czech Republic
Facility Name
Research Site
City
Cvikov
Country
Czech Republic
Facility Name
Research Site
City
Kladno
Country
Czech Republic
Facility Name
Research Site
City
Kolin 4
Country
Czech Republic
Facility Name
Research Site
City
Liberec
Country
Czech Republic
Facility Name
Research Site
City
Praha 10
Country
Czech Republic
Facility Name
Research Site
City
Praha 4
Country
Czech Republic
Facility Name
Research Site
City
Praha 6
Country
Czech Republic
Facility Name
Research Site
City
Rokycany
Country
Czech Republic
Facility Name
Research Site
City
Tabor
Country
Czech Republic
Facility Name
Research Site
City
Brest
Country
France
Facility Name
Research Site
City
Ferolles Attilly
Country
France
Facility Name
Research Site
City
Grasse
Country
France
Facility Name
Research Site
City
Grenoble
Country
France
Facility Name
Research Site
City
Marseille Cedex 06
Country
France
Facility Name
Research Site
City
Montpellier
Country
France
Facility Name
Research Site
City
Paris Cedex
Country
France
Facility Name
Research Site
City
St Laurent Du Var
Country
France
Facility Name
Research Site
City
Villejuif
Country
France
Facility Name
Research Site
City
Bad Wörishofen
Country
Germany
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Frankfurt
Country
Germany
Facility Name
Research Site
City
Freising
Country
Germany
Facility Name
Research Site
City
Gelnhausen
Country
Germany
Facility Name
Research Site
City
Gelsenkirchen
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Landsberg
Country
Germany
Facility Name
Research Site
City
Marburg
Country
Germany
Facility Name
Research Site
City
Nürnberg
Country
Germany
Facility Name
Research Site
City
Potsdam
Country
Germany
Facility Name
Research Site
City
Rodgau-dudenhofen
Country
Germany
Facility Name
Research Site
City
Wolmirstedt
Country
Germany
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Füzesabony
Country
Hungary
Facility Name
Research Site
City
Gyöngyös
Country
Hungary
Facility Name
Research Site
City
Győr
Country
Hungary
Facility Name
Research Site
City
Hódmezővásárhely
Country
Hungary
Facility Name
Research Site
City
Kaposvár
Country
Hungary
Facility Name
Research Site
City
Mosonmagyaróvár
Country
Hungary
Facility Name
Research Site
City
Szombathely
Country
Hungary
Facility Name
Research Site
City
Százhalombatta
Country
Hungary
Facility Name
Research Site
City
Cagliari
State/Province
CA
Country
Italy
Facility Name
Research Site
City
Crema
State/Province
CR
Country
Italy
Facility Name
Research Site
City
Firenze
State/Province
FI
Country
Italy
Facility Name
Research Site
City
Arenzano
State/Province
GE
Country
Italy
Facility Name
Research Site
City
Palermo
State/Province
PA
Country
Italy
Facility Name
Research Site
City
Pisa
State/Province
PI
Country
Italy
Facility Name
Research Site
City
Prato
State/Province
PO
Country
Italy
Facility Name
Research Site
City
Bussolengo
State/Province
VR
Country
Italy
Facility Name
Research Site
City
Verona
State/Province
VR
Country
Italy
Facility Name
Research Site
City
Napoli
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
Research Site
City
Zapopan
State/Province
Jalisco
Country
Mexico
Facility Name
Research Site
City
Morelia
State/Province
Michoacan
Country
Mexico
Facility Name
Research Site
City
Villahermosa
State/Province
Tabasco
Country
Mexico
Facility Name
Research Site
City
Mexico
Country
Mexico
Facility Name
Research Site
City
Bydgoszcz
Country
Poland
Facility Name
Research Site
City
Gdynia
Country
Poland
Facility Name
Research Site
City
Iława
Country
Poland
Facility Name
Research Site
City
Kraków
Country
Poland
Facility Name
Research Site
City
Piekary Śląskie
Country
Poland
Facility Name
Research Site
City
Skarżysko-Kamienna
Country
Poland
Facility Name
Research Site
City
Strzelce Opolskie
Country
Poland
Facility Name
Research Site
City
Tarnów
Country
Poland
Facility Name
Research Site
City
Zabrze
Country
Poland
Facility Name
Research Site
City
Łódź
Country
Poland
Facility Name
Research Site
City
Amadora
Country
Portugal
Facility Name
Research Site
City
Covilhã
Country
Portugal
Facility Name
Research Site
City
Porto
Country
Portugal
Facility Name
Research Site
City
Vila Nova de Gaia
Country
Portugal
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Kosice
Country
Slovakia
Facility Name
Research Site
City
Nove Zamky
Country
Slovakia
Facility Name
Research Site
City
Nové Zámky
Country
Slovakia
Facility Name
Research Site
City
Povazska Bystrica
Country
Slovakia
Facility Name
Research Site
City
Prievidza
Country
Slovakia
Facility Name
Research Site
City
Rimavska Sobota
Country
Slovakia
Facility Name
Research Site
City
Trenčín
Country
Slovakia
Facility Name
Research Site
City
Basel
State/Province
Basel Stadt
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
20110554
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=442&filename=CSR-D9618C00001.pdf
Description
CSR-D9618C00001.pdf
Learn more about this trial
Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma
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