Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00317044
First received: April 20, 2006
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Asthma
GERD
Drug: Esomeprazole
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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). [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    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)) [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: From randomization (Visit 3) to visit 7. ] [ Designated as safety issue: No ]
    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. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Randomization (Visit 3) to Visit 7 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Night [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Participants must have both baseline and follow up measure to be included in analysis


Enrollment: 961
Study Start Date: April 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Esomeprazole 40 mg twice daily Drug: Esomeprazole
Esomeprazole 40 mg twice daily
Experimental: Esomeprazole 40 mg once daily Drug: Esomeprazole
Esomeprazole 40 mg once daily
Placebo Comparator: Placebo Drug: Placebo
Placebo twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317044

  Hide Study Locations
Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, Arizona
Research Site
Scottsdale, Arizona, United States
United States, Arkansas
Research Site
Little Rock, Arkansas, United States
United States, California
Research Site
Fountain Valley, California, United States
United States, Florida
Research Site
Miami, Florida, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
Research Site
Stockbridge, Georgia, United States
United States, Illinois
Research Site
Normal, Illinois, United States
United States, Kansas
Research Site
Overland Park, Kansas, United States
Research Site
Wichita, Kansas, United States
United States, Louisiana
Research Site
Mandeville, Louisiana, United States
United States, Maryland
Research Site
Wheaton, Maryland, United States
United States, Missouri
Research Site
St. Louis, Missouri, United States
United States, Nebraska
Research Site
Papillion, Nebraska, United States
United States, North Carolina
Research Site
Asheville, North Carolina, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
Research Site
Sylvania, Ohio, United States
United States, Oregon
Research Site
Medford, Oregon, United States
United States, Pennsylvania
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Upland, Pennsylvania, United States
United States, South Carolina
Research Site
Charleston, South Carolina, United States
United States, Texas
Research Site
Austin, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
United States, Washington
Research Site
Kirkland, Washington, United States
Research Site
Seattle, Washington, United States
United States, Wisconsin
Research Site
Greenfield, Wisconsin, United States
Argentina
Research Site
Monte Grande, Buenos Aires, Argentina
Research Site
Quilmes, Buenos Aires, Argentina
Research Site
Córdoba, Córdoba, Argentina, Argentina
Research Site
Rosario, Santa Fe, Argentina, Argentina
Research Site
Rosario, Santa Fe, Argentina
Research Site
San Miguel De Tucumán, Tucumán, Argentina, Argentina
Research Site
Buenos Aires, Argentina
Research Site
Ciudad Autónoma de Buenos Aires, Argentina
Research Site
Ciudad de Buenos Aires, Argentina
Research Site
Córdoba, Argentina
Bulgaria
Research Site
Pleven, Bulgaria
Research Site
Plovdiv, Bulgaria
Research Site
Russe, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Varna, Bulgaria
Canada, Alberta
Research Site
Calgary, Alberta, Canada
Canada, Newfoundland and Labrador
Research Site
Bay Roberts, Newfoundland and Labrador, Canada
Research Site
Holyrood, Newfoundland and Labrador, Canada
Canada, Ontario
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
Canada, Quebec
Research Site
La Malbaie, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Canada
Research Site
Quebec, Canada
Czech Republic
Research Site
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
France
Research Site
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
Germany
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
Nürnberg, Germany
Research Site
Potsdam, Germany
Research Site
Rodgau-dudenhofen, Germany
Research Site
Wolmirstedt, Germany
Hungary
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
Szombathely, Hungary
Research Site
Százhalombatta, Hungary
Italy
Research Site
Cagliari, CA, Italy
Research Site
Crema, CR, Italy
Research Site
Firenze, FI, Italy
Research Site
Arenzano, GE, Italy
Research Site
Palermo, PA, Italy
Research Site
Pisa, PI, Italy
Research Site
Prato, PO, Italy
Research Site
Bussolengo, VR, Italy
Research Site
Verona, VR, Italy
Research Site
Napoli, Italy
Research Site
Roma, Italy
Mexico
Research Site
Guadalajara, Jalisco, Mexico
Research Site
Zapopan, Jalisco, Mexico
Research Site
Morelia, Michoacan, Mexico
Research Site
Villahermosa, Tabasco, Mexico
Research Site
Mexico, Mexico
Poland
Research Site
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
Portugal
Research Site
Amadora, Portugal
Research Site
Covilhã, Portugal
Research Site
Porto, Portugal
Research Site
Vila Nova de Gaia, Portugal
Slovakia
Research Site
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
Switzerland
Research Site
Basel, Basel Stadt, Switzerland
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Nexium Medical Science Director, MD AstraZeneca
  More Information

Additional Information:
No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00317044     History of Changes
Other Study ID Numbers: D9618C00001, RELAX
Study First Received: April 20, 2006
Results First Received: April 23, 2009
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Moderate to severe Asthma
Gastroesophageal Reflux Disease
esomeprazole
GERD

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Anti-Asthmatic Agents
Esomeprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014