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Study of Acid Reflux in Asthma

This study has been completed.
Sponsor:
Collaborators:
American Lung Association Asthma Clinical Research Centers
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert Wise, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00069823
First received: October 1, 2003
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
Results First Received: May 14, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Asthma
Lung Diseases
Lung Diseases, Obstructive
Interventions: Drug: Esomeprazole
Drug: Placebo proton pump inhibitor

  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
The planned enrollment was for 400 participants, 403 participants actually were enrolled and randomized in the trial. It is not uncommon for clinical trials not to exactly meet the sample size stated in the protocol.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo 40 mg of placebo twice daily
Esomeprazole 40 mg of esomeprazole twice daily

Participant Flow:   Overall Study
    Placebo     Esomeprazole  
STARTED     199 [1]   203 [1]
COMPLETED     193     200  
NOT COMPLETED     6     3  
Did not have follow-up diary cards                 6                 3  
[1] The design was for 200 participants per group, the study did not exactly meet the design.



  Baseline Characteristics
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Reporting Groups
  Description
Placebo 40 mg of placebo twice daily
Esomeprazole 40 mg of esomeprazole twice daily
Total Total of all reporting groups

Baseline Measures
    Placebo     Esomeprazole     Total  
Number of Participants  
[units: participants]
 		  199     203     402  
Age  
[units: years]
Mean ± Standard Deviation 		  42  ± 13     42  ± 13     42  ± 13  
Gender  
[units: participants]
 		     
Female     143     130     273  
Male     56     73     129  
Race/Ethnicity, Customized [1]
[units: participants]
 		     
White     103     102     205  
Black     73     79     152  
Hispanic     17     18     35  
Other     6     4     10  
Asthma medication use  
[units: participants]
 		     
Inhaled corticosteroids     50     44     94  
Combination of fluticasone and salmeterol     149     159     308  
Body-mass index >=30 [2]
[units: participants]
 		     
BMI >=30     107     102     209  
BMI <30     92     101     193  
Conditions other than asthma [3]
[units: participants]
 		     
Gastroesophageal reflux disease     38     21     59  
No GER reported     161     182     343  
Former smoker  
[units: participants]
 		     
Former Smoker     40     31     71  
Never smoked     159     172     331  
Health Care Visits [4]
[units: participants]
 		     
Health care visit for asthma exacerbation     126     109     235  
No visit     73     94     167  
Pulmonary function  
[units: participants]
 		     
Participants with 20% post-diluent measurement     92     83     175  
20% from post-diluent contraindicated     102     117     219  
Missing     5     3     8  
potential Hydrogen (pH) monitoring [5]
[units: participants]
 		     
Positive result     62     61     123  
Negative result     89     92     181  
Missing result     48     50     98  
%Predicted amount of air expired in the first second during a forced expiration pre broncho-dilator [6]
[units: Percent]
Mean ± Standard Deviation 		  78  ± 15     76  ± 16     77  ± 16  
Age of onset of asthma  
[units: years]
Mean ± Standard Deviation 		  17  ± 17     17  ± 16     17  ± 16  
Age of participants  
[units: years]
Mean ± Standard Deviation 		     
at randomization     42  ± 13     42  ± 13     42  ± 13  
at onset of asthma     17  ± 17     17  ± 16     17  ± 16  
Asthma scores [7]
[units: score]
Mean ± Standard Deviation 		     
ACQ     1.9  ± 0.8     1.8  ± 0.8     1.8  ± 0.8  
ASUI     0.74  ± 0.18     0.76  ± 0.15     0.75  ± 0.15  
mini asthma quality of life questionnaire     4.7  ± 1.2     4.7  ± 1.2     4.7  ± 1.2  
Percent change in FEV1 after bronchodilator [8]
[units: Percent change]
Mean ± Standard Deviation 		  10  ± 10     11  ± 16     11  ± 13  
[1] Race or ethnic group was self-reported.
[2] The body-mass index is the weight in kilograms divided by the square of the height in meters.
[3] These conditions were self-reported.
[4] Unscheduled health care visit for asthma in previous year
[5] Results of ambulatory measure of esophageal potential Hydrogen (pH) for 16 to 24 hours. Test were considered positive if pH was less than 4 for more than 5.8% of the total tiem, 8.2% of upright time, or 3.5% of supine time.
[6] Percent of the predicted value for the amount of air expired in the first second during a forced expiratory maneuver (FEV1) based on gender, age and ethnicity that the measured value is.
[7] Asthma Control Score (ACS)ranges from 0 to 6, lower scores indicating better asthma control and 0.5 as the minimal clinically important difference; Asthma Symptom Utility Index (ASUI) score ranges from 0 to 1, higher scores indicating less severe asthma; Mini-Asthma Quality of Life Questionnaire (mini-AQLQ) score range from 1 to 7, higher scores indicating better quality of life and 0.5 as the minimal clinically important difference.
[8] The percent difference in FEV1 before and after using a bronchodilator (albuterol) divided by the value before bronchodilation.



  Outcome Measures
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1.  Primary:   Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion   [ Time Frame: Baseline to 24 Weeks ]
  Show Outcome Measure 1

2.  Secondary:   Exacerbation Components: >=30% Drop in Peak Expiratory Flow on 2 Consecutive Days   [ Time Frame: Baseline to 24 Weeks ]
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3.  Secondary:   Exacerbation Components: Urgent Care Visit   [ Time Frame: Measured at Month 6 ]
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4.  Secondary:   Exacerbation Components: New Use of Oral Corticosteroids   [ Time Frame: Baseline to 24 Weeks ]
  Show Outcome Measure 4

5.  Secondary:   Asthma Episodes, According to Definition That Included Increased Use of Beta-agonists   [ Time Frame: Baseline to 24 Weeks ]
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6.  Secondary:   Use of Rescue Medications   [ Time Frame: Baseline to 24 Weeks ]
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7.  Secondary:   Night Awakening   [ Time Frame: Baseline to 24 Weeks ]
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8.  Secondary:   Pulmonary Function: Change in Prebronchodilator FEV1   [ Time Frame: Baseline to 24 Weeks ]
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9.  Secondary:   Pulmonary Function: Change in Prebronchodilator Forced Vital Capacity   [ Time Frame: Baseline to 24 Weeks ]
  Show Outcome Measure 9

10.  Secondary:   Pulmonary Function: Change in Peak Flow Rate   [ Time Frame: Baseline to 24 Weeks ]
  Show Outcome Measure 10

11.  Secondary:   Pulmonary Function: Change in PC20   [ Time Frame: Baseline to 24 Weeks ]
  Show Outcome Measure 11

12.  Secondary:   Change in Juniper Asthma Control Score(JACQ)   [ Time Frame: Baseline to 24 Weeks ]
  Show Outcome Measure 12

13.  Secondary:   Change in Asthma Symptom Utility Index (ASUI)   [ Time Frame: Baseline to 24 Weeks ]
  Show Outcome Measure 13

14.  Secondary:   Change in the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ)   [ Time Frame: Baseline to 24 Weeks ]
  Hide Outcome Measure 14

Measure Type Secondary
Measure Title Change in the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ)
Measure Description Mean change. Scores on the Mini-Asthma Quality of Life Questionnaire (mini-AQLQ)range from 1 to 7, with higher scores indicating better quality of life and 0.5 as the minimal clinically important difference.
Time Frame Baseline to 24 Weeks  
Safety Issue No  

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
Placebo 40 mg of placebo twice daily
Esomeprazole 40 mg of esomeprazole twice daily

Measured Values
    Placebo     Esomeprazole  
Number of Participants Analyzed  
[units: participants]
 		  191     201  
Change in the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ)  
[units: score]
Mean ( 95% Confidence Interval ) 		  0.3  
  ( 0.2 to 0.4 )   		  0.3  
  ( 0.2 to 0.4 )  


Statistical Analysis 1 for Change in the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ)
Groups [1] All groups
Method [2] Regression, Linear
P Value [3] 0.33
Mean Difference (Net) [4] -0.1
Standard Error of the mean ± 0.1
95% Confidence Interval ( -0.2 to 0.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group



15.  Secondary:   Change in Medical Outcomes Study Short-Form 36 Score Quality of Life Score: Physical Component   [ Time Frame: Baseline to 24 Weeks ]
  Show Outcome Measure 15

16.  Secondary:   Change in Medical Outcomes Study Short-Form 36 Quality of Life Score: Mental Component   [ Time Frame: Baseline to 24 Weeks ]
  Show Outcome Measure 16

17.  Secondary:   Change in Gastric Symptoms: Gastroesophageal Reflux Disease Symptom Assessment Scale Score   [ Time Frame: Baseline to 24 Weeks ]
  Show Outcome Measure 17

18.  Secondary:   Change in Number of Gastric Symptoms: No. of Symptoms   [ Time Frame: Baseline to 24 Weeks ]
  Show Outcome Measure 18


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Ellen Brown
Organization: Johns Hopkins University
phone: 443-287-3170
e-mail: ala-acrc@jhsph.edu


No publications provided by Johns Hopkins Bloomberg School of Public Health

Publications automatically indexed to this study:


Responsible Party: Robert Wise, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00069823     History of Changes
Other Study ID Numbers: 157, U01 HL72968
Study First Received: October 1, 2003
Results First Received: May 14, 2010
Last Updated: December 17, 2012
Health Authority: United States: Federal Government