Study of Acid Reflux in Asthma
This study has been completed.
Sponsor:
Johns Hopkins Bloomberg School of Public Health
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
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Results First Received: May 14, 2010
Study Type:  Interventional 

Study Design:  Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment 
Conditions: 
Asthma Lung Diseases Lung Diseases, Obstructive 
Interventions: 
Drug: Esomeprazole Drug: Placebo proton pump inhibitor 
Participant Flow
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. 
PreAssignment 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 followup diary cards  6  3 
^{[1]}  The design was for 200 participants per group, the study did not exactly meet the design. 

Baseline Characteristics
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 
Total  Total of all reporting groups 
Baseline Measures
Placebo  Esomeprazole  Total  

Overall Participants Analyzed [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  
Bodymass index >=30 ^{[1] } [Units: Participants] 

BMI >=30  107  102  209  
BMI <30  92  101  193  


Conditions other than asthma ^{[1] } [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 ^{[1] } [Units: Participants] 

Health care visit for asthma exacerbation  126  109  235  
No visit  73  94  167  


Pulmonary function [Units: Participants] 

Participants with 20% postdiluent measurement  92  83  175  
20% from postdiluent contraindicated  102  117  219  
Missing  5  3  8  
potential Hydrogen (pH) monitoring ^{[1] } [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 bronchodilator ^{[1] } [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 ^{[1] } [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 ^{[1] } [Units: Percent change] Mean (Standard Deviation) 
10 (10)  11 (16)  11 (13)  

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

Measure Title  Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Betaagonists as a Criterion 
Measure Description  Episodes of poor asthma control was defined as any one of the following: 2 consecutive days with a drop in peak flow >=30% of baseline; urgent care for asthma; or new use of oral corticosteroids for asthma 
Time Frame  Baseline to 24 Weeks 
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  

Participants Analyzed [Units: Participants] 
193  200 
Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Betaagonists as a Criterion [Units: Events per person year] 
2.3  2.5 
Statistical Analysis 1 for Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Betaagonists as a Criterion
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Negative binomial regression 
P Value ^{[4]}  0.66 
IncidenceRate Ratio ^{[5]}  1.1 
95% Confidence Interval  0.8 to 1.5 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

The rates of EPACs were compared using incidencerate ratios (IRR). IRR and P value were estimated with the use of negative binomial regression models with robust variance estimates.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
P values are for the treatment effect of esomeprazole as compared with placebo.  
[5]  Other relevant estimation information: 
No text entered. 
2. Secondary:  Exacerbation Components: >=30% Drop in Peak Expiratory Flow on 2 Consecutive Days [ Time Frame: Baseline to 24 Weeks ] 
Measure Type  Secondary 

Measure Title  Exacerbation Components: >=30% Drop in Peak Expiratory Flow on 2 Consecutive Days 
Measure Description  No text entered. 
Time Frame  Baseline to 24 Weeks 
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  

Participants Analyzed [Units: Participants] 
193  200 
Exacerbation Components: >=30% Drop in Peak Expiratory Flow on 2 Consecutive Days [Units: Events per personyear] 
1.7  2.1 
Statistical Analysis 1 for Exacerbation Components: >=30% Drop in Peak Expiratory Flow on 2 Consecutive Days
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Negative binomial regression 
P Value ^{[4]}  0.35 
IncidenceRate Ratio ^{[5]}  1.2 
95% Confidence Interval  0.8 to 2.0 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Rates were compared with incidencerate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
P values are for the treatment effect of esomeprazole as compared with placebo.  
[5]  Other relevant estimation information: 
No text entered. 
3. Secondary:  Exacerbation Components: Urgent Care Visit [ Time Frame: Measured at Month 6 ] 
Measure Type  Secondary 

Measure Title  Exacerbation Components: Urgent Care Visit 
Measure Description  No text entered. 
Time Frame  Measured at Month 6 
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  

Participants Analyzed [Units: Participants] 
193  200 
Exacerbation Components: Urgent Care Visit [Units: Events per personyear] 
0.6  0.5 
Statistical Analysis 1 for Exacerbation Components: Urgent Care Visit
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Negative binomial regression 
P Value ^{[4]}  0.79 
IncidenceRate Ratio ^{[5]}  0.9 
95% Confidence Interval  0.6 to 1.5 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Rates were compared with incidencerate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
P values are for the treatment effect of esomeprazole as compared with placebo.  
[5]  Other relevant estimation information: 
No text entered. 
4. Secondary:  Exacerbation Components: New Use of Oral Corticosteroids [ Time Frame: Baseline to 24 Weeks ] 
Measure Type  Secondary 

Measure Title  Exacerbation Components: New Use of Oral Corticosteroids 
Measure Description  No text entered. 
Time Frame  Baseline to 24 Weeks 
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  

Participants Analyzed [Units: Participants] 
193  200 
Exacerbation Components: New Use of Oral Corticosteroids [Units: Events per person year] 
0.6  0.5 
Statistical Analysis 1 for Exacerbation Components: New Use of Oral Corticosteroids
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Negative binomial regression 
P Value ^{[4]}  0.62 
IncidenceRate Ratio ^{[5]}  0.9 
95% Confidence Interval  0.6 to 1.3 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Rates were compared with incidencerate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
P values are for the treatment effect of esomeprazole as compared with placebo.  
[5]  Other relevant estimation information: 
No text entered. 
5. Secondary:  Asthma Episodes, According to Definition That Included Increased Use of Betaagonists [ Time Frame: Baseline to 24 Weeks ] 
Measure Type  Secondary 

Measure Title  Asthma Episodes, According to Definition That Included Increased Use of Betaagonists 
Measure Description  No text entered. 
Time Frame  Baseline to 24 Weeks 
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  

Participants Analyzed [Units: Participants] 
193  200 
Asthma Episodes, According to Definition That Included Increased Use of Betaagonists [Units: Events per personyear] 
4.4  4.3 
Statistical Analysis 1 for Asthma Episodes, According to Definition That Included Increased Use of Betaagonists
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Negative binomial regression 
P Value ^{[4]}  0.87 
IncidenceRate Ratio ^{[5]}  1.0 
95% Confidence Interval  0.8 to 1.3 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Rates were compared with incidencerate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
P values are for the treatment effect of esomeprazole as compared with placebo.  
[5]  Other relevant estimation information: 
No text entered. 
6. Secondary:  Use of Rescue Medications [ Time Frame: Baseline to 24 Weeks ] 
Measure Type  Secondary 

Measure Title  Use of Rescue Medications 
Measure Description  Increase in the use of rescue meds by 4 or more uses on a particular day above the average uses during the runin period. 
Time Frame  Baseline to 24 Weeks 
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  

Participants Analyzed [Units: Participants] 
193  200 
Use of Rescue Medications [Units: Events per personyear] 
3.0  2.8 
Statistical Analysis 1 for Use of Rescue Medications
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Negative binomial regression 
P Value ^{[4]}  0.62 
IncidenceRate Ratio ^{[5]}  0.9 
95% Confidence Interval  0.7 to 1.3 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Incidencerate ratios and P values were estimated with the use of negative binomial regression models with robust variance estimates.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
P values are for the treatment effect of esomeprazole as compared with placebo.  
[5]  Other relevant estimation information: 
No text entered. 
7. Secondary:  Night Awakening [ Time Frame: Baseline to 24 Weeks ] 
Measure Type  Secondary 

Measure Title  Night Awakening 
Measure Description  Rate of awakening at night because of asthma symptoms 
Time Frame  Baseline to 24 Weeks 
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  

Participants Analyzed [Units: Participants] 
193  200 
Night Awakening [Units: Events per personyear] 
30  28 
Statistical Analysis 1 for Night Awakening
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Negative binomial regression 
P Value ^{[4]}  0.70 
IncidenceRate Ratio ^{[5]}  0.9 
95% Confidence Interval  0.6 to 1.4 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Incidencerate ratios and P values were estimated with the use of negative binomial regression models with robust variance estimates.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
P values are for the treatment effect of esomeprazole as compared with placebo.  
[5]  Other relevant estimation information: 
No text entered. 
8. Secondary:  Pulmonary Function: Change in Prebronchodilator FEV1 [ Time Frame: Baseline to 24 Weeks ] 
Measure Type  Secondary 

Measure Title  Pulmonary Function: Change in Prebronchodilator FEV1 
Measure Description  Mean change in prebronchodilator FEV1  forced expiratory volume in 1 second; a measure of pulmonary function. The treatment effect is the difference in the mean change in between the groups. 
Time Frame  Baseline to 24 Weeks 
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. 

The analyses are based on data from 191 participants in the placebo group and 201 in the esomeprazole group, with the following exception: 41 participants in the placebo group and 37 in the esomeprazole group for measurement of 20% postdiluent baseline (PC20). 
Reporting Groups
Description  

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

Participants Analyzed [Units: Participants] 
191  201 
Pulmonary Function: Change in Prebronchodilator FEV1 [Units: Liters] Mean (95% Confidence Interval) 
0.02 (0.06 to 0.01) 
0.00 (0.04 to 0.04) 
Statistical Analysis 1 for Pulmonary Function: Change in Prebronchodilator FEV1
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.36 
Mean Difference (Net) ^{[5]}  0.03 
95% Confidence Interval  0.03 to 0.08 
Standard Error of the mean  (0.03) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

The treatment effect is the mean change in the Esomeprazole group  mean change in placebo group  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
P values were calculated with the use of linear regression.  
[5]  Other relevant estimation information: 
Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group, e.g. 0.00  (0.02) = 0.03 (rounding) 
9. Secondary:  Pulmonary Function: Change in Prebronchodilator Forced Vital Capacity [ Time Frame: Baseline to 24 Weeks ] 
Measure Type  Secondary 

Measure Title  Pulmonary Function: Change in Prebronchodilator Forced Vital Capacity 
Measure Description  Pulmonary function measured by mean change in Prebronchodilator forced vital capacity from baseline to 24 weeks 
Time Frame  Baseline to 24 Weeks 
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  

Participants Analyzed [Units: Participants] 
191  201 
Pulmonary Function: Change in Prebronchodilator Forced Vital Capacity [Units: Liters] Mean (95% Confidence Interval) 
0.03 (0.06 to 0.01) 
0.00 (0.04 to 0.05) 
Statistical Analysis 1 for Pulmonary Function: Change in Prebronchodilator Forced Vital Capacity
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.30 
Mean Difference (Final Values) ^{[5]}  0.03 
95% Confidence Interval  0.03 to 0.09 
Standard Error of the mean  (0.03) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group 
10. Secondary:  Pulmonary Function: Change in Peak Flow Rate [ Time Frame: Baseline to 24 Weeks ] 
Measure Type  Secondary 

Measure Title  Pulmonary Function: Change in Peak Flow Rate 
Measure Description  Mean change from baseline to 24 weeks in the peak flow rate  how forceful patient can blow out air 
Time Frame  Baseline to 24 Weeks 
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  

Participants Analyzed [Units: Participants] 
191  201 
Pulmonary Function: Change in Peak Flow Rate [Units: Liters/min] Mean (95% Confidence Interval) 
3.2 (3.5 to 9.9) 
9.2 (1.8 to 16.6) 
Statistical Analysis 1 for Pulmonary Function: Change in Peak Flow Rate
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.24 
Mean Difference (Final Values) ^{[5]}  6.0 
95% Confidence Interval  4.0 to 16.0 
Standard Error of the mean  (5.1) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group 
11. Secondary:  Pulmonary Function: Change in PC20 [ Time Frame: Baseline to 24 Weeks ] 
Measure Type  Secondary 

Measure Title  Pulmonary Function: Change in PC20 
Measure Description  Mean Change in the dose of methacholine that results in a 20% drop in FEV1 
Time Frame  Baseline to 24 Weeks 
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  

Participants Analyzed [Units: Participants] 
41  37 
Pulmonary Function: Change in PC20 [Units: Mg/ml] Mean (95% Confidence Interval) 
1.5 (0.2 to 2.9) 
0.3 (1.4 to 0.9) 
Statistical Analysis 1 for Pulmonary Function: Change in PC20
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.04 
Treatment Effect ^{[5]}  1.8 
95% Confidence Interval  3.6 to 0.1 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
12. Secondary:  Change in Juniper Asthma Control Score(JACQ) [ Time Frame: Baseline to 24 Weeks ] 
Measure Type  Secondary 

Measure Title  Change in Juniper Asthma Control Score(JACQ) 
Measure Description  Mean change. Scores on the JACQ range from 0 to 6, with lower scores indicating better asthma control and 0.5 as the minimal clinically important difference. 
Time Frame  Baseline to 24 Weeks 
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  

Participants Analyzed [Units: Participants] 
191  201 
Change in Juniper Asthma Control Score(JACQ) [Units: Score] Mean (95% Confidence Interval) 
0.3 (0.4 to 0.2) 
0.2 (0.3 to 0.1) 
Statistical Analysis 1 for Change in Juniper Asthma Control Score(JACQ)
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.11 
Treatment Effect ^{[5]}  0.1 
95% Confidence Interval  0.0 to 0.2 
Standard Error of the mean  (0.1) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group 
13. Secondary:  Change in Asthma Symptom Utility Index (ASUI) [ Time Frame: Baseline to 24 Weeks ] 
Measure Type  Secondary 

Measure Title  Change in Asthma Symptom Utility Index (ASUI) 
Measure Description  Mean change. Scores on the ASUI range from 0 to 1, with higher scores indicating less severe asthma. 
Time Frame  Baseline to 24 Weeks 
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  

Participants Analyzed [Units: Participants] 
191  201 
Change in Asthma Symptom Utility Index (ASUI) [Units: Score] Mean (95% Confidence Interval) 
0.05 (0.03 to 0.07) 
0.02 (0.01 to 0.04) 
Statistical Analysis 1 for Change in Asthma Symptom Utility Index (ASUI)
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.11 
Mean Difference (Final Values) ^{[5]}  0.02 
95% Confidence Interval  0.05 to 0.02 
Standard Error of the mean  (0.01) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group 
14. Secondary:  Change in the MiniAsthma Quality of Life Questionnaire (MiniAQLQ) [ Time Frame: Baseline to 24 Weeks ] 
Measure Type  Secondary 

Measure Title  Change in the MiniAsthma Quality of Life Questionnaire (MiniAQLQ) 
Measure Description  Mean change. Scores on the MiniAsthma Quality of Life Questionnaire (miniAQLQ)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 
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  

Participants Analyzed [Units: Participants] 
191  201 
Change in the MiniAsthma Quality of Life Questionnaire (MiniAQLQ) [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 MiniAsthma Quality of Life Questionnaire (MiniAQLQ)
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.33 
Mean Difference (Net) ^{[5]}  0.1 
95% Confidence Interval  0.2 to 0.1 
Standard Error of the mean  (0.1) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  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 ShortForm 36 Score Quality of Life Score: Physical Component [ Time Frame: Baseline to 24 Weeks ] 
Measure Type  Secondary 

Measure Title  Change in Medical Outcomes Study ShortForm 36 Score Quality of Life Score: Physical Component 
Measure Description  Mean change. Scores on the Medical Outcomes Study ShortForm 36 range from 1 to 100, with higher scores indicating better quality of life and 5 as the minimal clinically important difference. 
Time Frame  Baseline to 24 Weeks 
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  

Participants Analyzed [Units: Participants] 
191  201 
Change in Medical Outcomes Study ShortForm 36 Score Quality of Life Score: Physical Component [Units: Score] Mean (95% Confidence Interval) 
2.0 (1.1 to 2.9) 
1.1 (0.3 to 1.9) 
Statistical Analysis 1 for Change in Medical Outcomes Study ShortForm 36 Score Quality of Life Score: Physical Component
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.16 
Mean Difference (Net) ^{[5]}  0.9 
95% Confidence Interval  2.0 to 0.4 
Standard Error of the mean  (0.6) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group 
16. Secondary:  Change in Medical Outcomes Study ShortForm 36 Quality of Life Score: Mental Component [ Time Frame: Baseline to 24 Weeks ] 
Measure Type  Secondary 

Measure Title  Change in Medical Outcomes Study ShortForm 36 Quality of Life Score: Mental Component 
Measure Description  Mean change. Scores on the Medical Outcomes Study ShortForm 36 range from 1 to 100, with higher scores indicating better quality of life and 5 as the minimal clinically important difference. 
Time Frame  Baseline to 24 Weeks 
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  

Participants Analyzed [Units: Participants] 
191  201 
Change in Medical Outcomes Study ShortForm 36 Quality of Life Score: Mental Component [Units: Score] Mean (95% Confidence Interval) 
0.0 (1.8 to 1.1) 
0.4 (0.5 to 1.4) 
Statistical Analysis 1 for Change in Medical Outcomes Study ShortForm 36 Quality of Life Score: Mental Component
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.56 
Mean Difference (Net) ^{[5]}  0.5 
95% Confidence Interval  1.1 to 2.2 
Standard Error of the mean  (0.78) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group 
17. Secondary:  Change in Gastric Symptoms: Gastroesophageal Reflux Disease Symptom Assessment Scale Score [ Time Frame: Baseline to 24 Weeks ] 
Measure Type  Secondary 

Measure Title  Change in Gastric Symptoms: Gastroesophageal Reflux Disease Symptom Assessment Scale Score 
Measure Description  Mean change. The Gastroesophageal Reflux Disease Symptom Assessment Scale score ranges from 0 to 3, with lower numbers indicating less distress. 
Time Frame  Baseline to 24 Weeks 
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  

Participants Analyzed [Units: Participants] 
191  201 
Change in Gastric Symptoms: Gastroesophageal Reflux Disease Symptom Assessment Scale Score [Units: Score] Mean (95% Confidence Interval) 
0.17 (0.21 to 0.12) 
0.16 (0.20 to 0.11) 
Statistical Analysis 1 for Change in Gastric Symptoms: Gastroesophageal Reflux Disease Symptom Assessment Scale Score
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.76 
Mean Difference (Net) ^{[5]}  0.01 
95% Confidence Interval  0.05 to 0.07 
Standard Error of the mean  (0.03) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group 
18. Secondary:  Change in Number of Gastric Symptoms: No. of Symptoms [ Time Frame: Baseline to 24 Weeks ] 
Measure Type  Secondary 

Measure Title  Change in Number of Gastric Symptoms: No. of Symptoms 
Measure Description  Mean change 
Time Frame  Baseline to 24 Weeks 
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  

Participants Analyzed [Units: Participants] 
191  201 
Change in Number of Gastric Symptoms: No. of Symptoms [Units: Symptoms] Mean (95% Confidence Interval) 
1.7 (2.1 to 1.3) 
1.9 (2.3 to 1.6) 
Statistical Analysis 1 for Change in Number of Gastric Symptoms: No. of Symptoms
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Regression, Linear 
P Value ^{[4]}  0.39 
Mean Difference (Net) ^{[5]}  0.2 
95% Confidence Interval  0.8 to 0.3 
Standard Error of the mean  (0.3) 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group 
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 

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