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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
Results First Received: April 23, 2009  
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
Conditions: Asthma
GERD
Interventions: Drug: Esomeprazole
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Four randomized patients were excluded from the ITT analysis due to missing efficacy data (2 patients), no investigational product given (1 patient), and being unblinded by the investigator (1 patient). The patient who received no investigational product was excluded from the safety analysis and is not included in the Baseline Characteristics.

Reporting Groups
  Description
Esomeprazole 40 mg Twice Daily Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
Esomeprazole 40 mg Once Daily Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
Placebo Placebo

Participant Flow:   Overall Study
    Esomeprazole 40 mg Twice Daily     Esomeprazole 40 mg Once Daily     Placebo  
STARTED     320     313     328  
COMPLETED     272     273     283  
NOT COMPLETED     48     40     45  
Protocol Violation                 28                 22                 20  
Adverse Event                 4                 7                 4  
Withdrawal by Subject                 10                 7                 12  
Lost to Follow-up                 0                 2                 3  
Multiple Reasons                 6                 2                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Esomeprazole 40 mg Twice Daily Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
Esomeprazole 40 mg Once Daily Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
    Esomeprazole 40 mg Twice Daily     Esomeprazole 40 mg Once Daily     Placebo     Total  
Number of Participants  
[units: participants]
  319     313     328     960  
Age  
[units: Years]
Mean ( Full Range )
  44.0  
  ( 18 to 69 )  
  45.0  
  ( 19 to 70 )  
  45.0  
  ( 18 to 70 )  
  44.667  
  ( 18 to 70 )  
Gender  
[units: Participants]
       
Female     240.00     240.00     247.00     727  
Male     79.00     73.00     81.00     233  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute))   [ Time Frame: Baseline to 6 months ]

3.  Secondary:   Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total   [ Time Frame: Baseline to 6 months ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   Change in Forced Expiratory Volume in 1 Second (FEV1) From Randomization to Treatment Period.   [ Time Frame: From randomization (Visit 3) to visit 7. ]

7.  Secondary:   Number of Patients With Severe Asthma Exacerbations.   [ Time Frame: Up to 6 months ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]

10.  Secondary:   Number of Severe Adverse Events   [ Time Frame: Up to 6 months ]

11.  Secondary:   Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Night   [ Time Frame: Baseline to 6 months ]

12.  Secondary:   Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Day   [ Time Frame: Baseline to 6 months ]

13.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Numbers of patients analyzed in each of the Outcome Measures varies due to the amount of qualifying data captured for the patients.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: ClinicalTrialTransparency
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

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