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

May 9, 2014 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

961

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Ciudad Autónoma de Buenos Aires, Argentina
        • Research Site
      • Ciudad de Buenos Aires, Argentina
        • Research Site
      • Córdoba, Argentina
        • Research Site
    • Buenos Aires
      • Monte Grande, Buenos Aires, Argentina
        • Research Site
      • Quilmes, Buenos Aires, Argentina
        • Research Site
    • Córdoba, Argentina
      • Córdoba, Córdoba, Argentina, Argentina
        • Research Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Research Site
    • Santa Fe, Argentina
      • Rosario, Santa Fe, Argentina, Argentina
        • Research Site
    • Tucumán, Argentina
      • San Miguel De Tucumán, Tucumán, Argentina, Argentina
        • Research Site
  • Bulgaria
      • Pleven, Bulgaria
        • Research Site
      • Plovdiv, Bulgaria
        • Research Site
      • Russe, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
  • Canada
      • Quebec, Canada
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada
        • Research Site
      • Holyrood, Newfoundland and Labrador, Canada
        • Research Site
    • Ontario
      • 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
    • Quebec
      • La Malbaie, Quebec, Canada
        • Research Site
      • Montreal, Quebec, Canada
        • Research Site
  • Czech Republic
      • Benesov U Prahy, Czech Republic
        • Research Site
      • Beroun, Czech Republic
        • Research Site
      • Cvikov, Czech Republic
        • Research Site
      • Kladno, Czech Republic
        • Research Site
      • Kolin 4, Czech Republic
        • Research Site
      • Liberec, Czech Republic
        • Research Site
      • Praha 10, Czech Republic
        • Research Site
      • Praha 4, Czech Republic
        • Research Site
      • Praha 6, Czech Republic
        • Research Site
      • Rokycany, Czech Republic
        • Research Site
      • Tabor, Czech Republic
        • Research Site
  • France
      • Brest, France
        • Research Site
      • Ferolles Attilly, France
        • Research Site
      • Grasse, France
        • Research Site
      • Grenoble, France
        • Research Site
      • Marseille Cedex 06, France
        • Research Site
      • Montpellier, France
        • Research Site
      • Paris Cedex, France
        • Research Site
      • St Laurent Du Var, France
        • Research Site
      • Villejuif, France
        • Research Site
  • Germany
      • 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
      • Nürnberg, Germany
        • Research Site
      • Potsdam, Germany
        • Research Site
      • Rodgau-dudenhofen, Germany
        • Research Site
      • Wolmirstedt, Germany
        • Research Site
  • Hungary
      • 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
      • Szombathely, Hungary
        • Research Site
      • Százhalombatta, Hungary
        • Research Site
  • Italy
      • Napoli, Italy
        • Research Site
      • Roma, Italy
        • Research Site
    • CA
      • Cagliari, CA, Italy
        • Research Site
    • CR
      • Crema, CR, Italy
        • Research Site
    • FI
      • Firenze, FI, Italy
        • Research Site
    • GE
      • Arenzano, GE, Italy
        • Research Site
    • PA
      • Palermo, PA, Italy
        • Research Site
    • PI
      • Pisa, PI, Italy
        • Research Site
    • PO
      • Prato, PO, Italy
        • Research Site
    • VR
      • Bussolengo, VR, Italy
        • Research Site
      • Verona, VR, Italy
        • Research Site
  • Mexico
      • Mexico, Mexico
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Research Site
      • Zapopan, Jalisco, Mexico
        • Research Site
    • Michoacan
      • Morelia, Michoacan, Mexico
        • Research Site
    • Tabasco
      • Villahermosa, Tabasco, Mexico
        • Research Site
  • Poland
      • Bydgoszcz, Poland
        • Research Site
      • Gdynia, Poland
        • Research Site
      • Iława, Poland
        • Research Site
      • Kraków, 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
      • Łódź, Poland
        • Research Site
  • Portugal
      • Amadora, Portugal
        • Research Site
      • Covilhã, Portugal
        • Research Site
      • Porto, Portugal
        • Research Site
      • Vila Nova de Gaia, Portugal
        • Research Site
  • Slovakia
      • Bratislava, Slovakia
        • Research Site
      • Kosice, Slovakia
        • Research Site
      • Nove Zamky, Slovakia
        • Research Site
      • Nové Zámky, Slovakia
        • Research Site
      • Povazska Bystrica, Slovakia
        • Research Site
      • Prievidza, Slovakia
        • Research Site
      • Rimavska Sobota, Slovakia
        • Research Site
      • Trenčín, Slovakia
        • Research Site
  • Switzerland
    • Basel Stadt
      • Basel, Basel Stadt, Switzerland
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
    • Arizona
      • Scottsdale, Arizona, United States
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Research Site
    • California
      • Fountain Valley, California, United States
        • Research Site
    • Florida
      • Miami, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
      • Stockbridge, Georgia, United States
        • Research Site
    • Illinois
      • Normal, Illinois, United States
        • Research Site
    • Kansas
      • Overland Park, Kansas, United States
        • Research Site
      • Wichita, Kansas, United States
        • Research Site
    • Louisiana
      • Mandeville, Louisiana, United States
        • Research Site
    • Maryland
      • Wheaton, Maryland, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • Nebraska
      • Papillion, Nebraska, United States
        • Research Site
    • North Carolina
      • Asheville, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Sylvania, Ohio, United States
        • Research Site
    • Oregon
      • Medford, Oregon, United States
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Research Site
      • Upland, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Washington
      • Kirkland, Washington, United States
        • Research Site
      • Seattle, Washington, United States
        • Research Site
    • Wisconsin
      • Greenfield, Wisconsin, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo twice daily
Experimental: Esomeprazole 40 mg twice daily
Drug: Esomeprazole
Esomeprazole 40 mg twice daily
Drug: Esomeprazole
Esomeprazole 40 mg once daily
Experimental: Esomeprazole 40 mg once daily
Drug: Esomeprazole
Esomeprazole 40 mg twice daily
Drug: Esomeprazole
Esomeprazole 40 mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: Baseline to 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute))
Time Frame: Baseline to 6 months
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.
Baseline to 6 months
Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total
Time Frame: Baseline to 6 months
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.
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
Time Frame: 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.
Baseline to 6 months
Changes in Average Value From Baseline to Treatment Period in Percentage of Nights With Awakening(s) Due to Asthma
Time Frame: Baseline to 6 months
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.
Baseline to 6 months
Change in Forced Expiratory Volume in 1 Second (FEV1) From Randomization to Treatment Period.
Time Frame: From randomization (Visit 3) to visit 7.
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.
From randomization (Visit 3) to visit 7.
Number of Patients With Severe Asthma Exacerbations.
Time Frame: Up to 6 months
Up to 6 months
Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S)) Scores From Randomization (Visit 3) to Visit 7
Time Frame: 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).
From randomization (Visit 3) to Visit 7
Change in Symptoms of GERD as Measured by Reflux Disease Questionnaire (RDQ) From Randomization (Visit 3) to Visit 7
Time Frame: 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.
Randomization (Visit 3) to Visit 7
Number of Severe Adverse Events
Time Frame: Up to 6 months
Up to 6 months
Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Night
Time Frame: Baseline to 6 months
Participants must have both baseline and follow up measure to be included in analysis
Baseline to 6 months
Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Day
Time Frame: Baseline to 6 months
Participants must have both baseline and follow up measure to be included in analysis
Baseline to 6 months
Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Night
Time Frame: Baseline to 6 months
Participants must have both baseline and follow up measure to be included in analysis
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Nexium Medical Science Director, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

April 20, 2006

First Submitted That Met QC Criteria

April 20, 2006

First Posted (Estimate)

April 24, 2006

Study Record Updates

Last Update Posted (Estimate)

June 9, 2014

Last Update Submitted That Met QC Criteria

May 9, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9618C00001
  • RELAx

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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