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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

April 20, 2006
May 9, 2014
April 2006
July 2008   (final data collection date for primary outcome 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). [ 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.
Primary objective is to compare the anti-asthmatic effect of esomeprazole with that of placebo in adult asthmatics with gastroesophageal reflux by evaluating change in morning Peak Expiratory Flow from baseline (run-in) to treatment period.
Complete list of historical versions of study NCT00317044 on ClinicalTrials.gov Archive Site
  • 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
Secondary objectives are to investigate the effect on symptoms of GERD as measured by Reflux Disease Questionnaire from randomization to end of study and to assess safety and tolerability by AEs, laboratory tests, physical examination, and vital signs.
Not Provided
Not Provided
 
Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Asthma
  • GERD
  • Drug: Esomeprazole
    Esomeprazole 40 mg twice daily
  • Drug: Esomeprazole
    Esomeprazole 40 mg once daily
  • Drug: Placebo
    Placebo twice daily
  • Experimental: Esomeprazole 40 mg twice daily
    Intervention: Drug: Esomeprazole
  • Experimental: Esomeprazole 40 mg once daily
    Intervention: Drug: Esomeprazole
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
961
July 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Bulgaria,   Canada,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Mexico,   Poland,   Portugal,   Slovakia,   Switzerland
 
NCT00317044
D9618C00001, RELAX
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: AstraZeneca Nexium Medical Science Director, MD AstraZeneca
AstraZeneca
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP