Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma
RELAX
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
2 other identifiers
interventional
961
14 countries
130
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Apr 2006
Typical duration for phase_2 asthma
130 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 20, 2006
CompletedFirst Posted
Study publicly available on registry
April 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
June 9, 2014
CompletedJune 9, 2014
May 1, 2014
2.3 years
April 20, 2006
April 23, 2009
May 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline to 6 months
Secondary Outcomes (12)
Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute))
Baseline to 6 months
Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total
Baseline to 6 months
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
Baseline to 6 months
Changes in Average Value From Baseline to Treatment Period in Percentage of Nights With Awakening(s) Due to Asthma
Baseline to 6 months
Change in Forced Expiratory Volume in 1 Second (FEV1) From Randomization to Treatment Period.
From randomization (Visit 3) to visit 7.
- +7 more secondary outcomes
Study Arms (3)
Esomeprazole 40 mg twice daily
EXPERIMENTALEsomeprazole 40 mg once daily
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (130)
Research Site
Birmingham, Alabama, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Fountain Valley, California, United States
Research Site
Miami, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Stockbridge, Georgia, United States
Research Site
Normal, Illinois, United States
Research Site
Overland Park, Kansas, United States
Research Site
Wichita, Kansas, United States
Research Site
Mandeville, Louisiana, United States
Research Site
Wheaton, Maryland, United States
Research Site
St Louis, Missouri, United States
Research Site
Papillion, Nebraska, United States
Research Site
Asheville, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Sylvania, Ohio, United States
Research Site
Medford, Oregon, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Upland, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Site
Austin, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Kirkland, Washington, United States
Research Site
Seattle, Washington, United States
Research Site
Greenfield, Wisconsin, United States
Research Site
Ciudad de Buenos Aires, Argentina, Argentina
Research Site
Monte Grande, Buenos Aires, Argentina
Research Site
Quilmes, Buenos Aires, Argentina
Research Site
Córdoba, Córdoba Province, Argentina
Research Site
Córdoba, Córdoba, Argentina, Argentina
Research Site
Rosario, Santa Fe Province, Argentina
Research Site
Rosario, Santa Fe, Argentina, Argentina
Research Site
San Miguel de Tucumán, Tucumán, Argentina, Argentina
Research Site
Buenos Aires, Argentina
Research Site
Pleven, Bulgaria
Research Site
Plovdiv, Bulgaria
Research Site
Rousse, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Varna, Bulgaria
Research Site
Calgary, Alberta, Canada
Research Site
Bay Roberts, Newfoundland and Labrador, Canada
Research Site
Holyrood, Newfoundland and Labrador, Canada
Research Site
Brampton, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Mississauga, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Woodstock, Ontario, Canada
Research Site
La Malbaie, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Benesov U Prahy, Czechia
Research Site
Beroun, Czechia
Research Site
Cvikov, Czechia
Research Site
Kladno, Czechia
Research Site
Kolín, Czechia
Research Site
Liberec, Czechia
Research Site
Prague, Czechia
Research Site
Rokycany, Czechia
Research Site
Tábor, Czechia
Research Site
Brest, France
Research Site
Férolles-Attilly, France
Research Site
Grasse, France
Research Site
Grenoble, France
Research Site
Marseille, France
Research Site
Montpellier, France
Research Site
Paris, France
Research Site
Saint-Laurent-du-Var, France
Research Site
Villejuif, France
Research Site
Bad Wörishofen, Germany
Research Site
Berlin, Germany
Research Site
Frankfurt, Germany
Research Site
Freising, Germany
Research Site
Gelnhausen, Germany
Research Site
Gelsenkirchen, Germany
Research Site
Hamburg, Germany
Research Site
Landsberg, Germany
Research Site
Marburg, Germany
Research Site
Nuremberg, Germany
Research Site
Potsdam, Germany
Research Site
Rodgau-dudenhofen, Germany
Research Site
Wolmirstedt, Germany
Research Site
Budapest, Hungary
Research Site
Füzesabony, Hungary
Research Site
Gyöngyös, Hungary
Research Site
Győr, Hungary
Research Site
Hódmezővásárhely, Hungary
Research Site
Kaposvár, Hungary
Research Site
Mosonmagyaróvár, Hungary
Research Site
Százhalombatta, Hungary
Research Site
Szombathely, Hungary
Research Site
Cagliari, CA, Italy
Research Site
Crema, CR, Italy
Research Site
Florence, FI, Italy
Research Site
Arenzano, GE, Italy
Research Site
Palermo, PA, Italy
Research Site
Pisa, PI, Italy
Research Site
Prato, PO, Italy
Research Site
Roma, Roma, Italy
Research Site
Bussolengo, VR, Italy
Research Site
Verona, VR, Italy
Research Site
Napoli, Italy
Research Site
Guadalajara, Jalisco, Mexico
Research Site
Zapopan, Jalisco, Mexico
Research Site
Morelia, Michoacán, Mexico
Research Site
Villahermosa, Tabasco, Mexico
Research Site
México, Mexico
Research Site
Bydgoszcz, Poland
Research Site
Gdynia, Poland
Research Site
Iława, Poland
Research Site
Krakow, Poland
Research Site
Lodz, Poland
Research Site
Piekary Śląskie, Poland
Research Site
Skarżysko-Kamienna, Poland
Research Site
Strzelce Opolskie, Poland
Research Site
Tarnów, Poland
Research Site
Zabrze, Poland
Research Site
Amadora, Portugal
Research Site
Covilha, Portugal
Research Site
Porto, Portugal
Research Site
Vila Nova de Gaia, Portugal
Research Site
Bratislava, Slovakia
Research Site
Košice, Slovakia
Research Site
Nové Zámky, Slovakia
Research Site
Považská Bystrica, Slovakia
Research Site
Prievidza, Slovakia
Research Site
Rimavská Sobota, Slovakia
Research Site
Trenčín, Slovakia
Research Site
Basel, Canton of Basel-City, Switzerland
Related Publications (1)
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.
PMID: 20110554DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Numbers of patients analyzed in each of the Outcome Measures varies due to the amount of qualifying data captured for the patients.
Results Point of Contact
- Title
- ClinicalTrialTransparency
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
AstraZeneca Nexium Medical Science Director, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2006
First Posted
April 24, 2006
Study Start
April 1, 2006
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
June 9, 2014
Results First Posted
June 9, 2014
Record last verified: 2014-05