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Study of Acid Reflux in Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00069823
Recruitment Status : Completed
First Posted : October 3, 2003
Results First Posted : October 19, 2012
Last Update Posted : December 19, 2012
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

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
Enrollment 403
Recruitment Details 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  
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description 40 mg of placebo twice daily 40 mg of esomeprazole twice daily
Period Title: Overall Study
Started 199 [1] 203 [1]
Completed 193 200
Not Completed 6 3
Reason Not Completed
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.
Arm/Group Title Placebo Esomeprazole Total
Hide Arm/Group Description 40 mg of placebo twice daily 40 mg of esomeprazole twice daily Total of all reporting groups
Overall Number of Baseline Participants 199 203 402
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 199 participants 203 participants 402 participants
42  (13) 42  (13) 42  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 199 participants 203 participants 402 participants
Female
143
  71.9%
130
  64.0%
273
  67.9%
Male
56
  28.1%
73
  36.0%
129
  32.1%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 199 participants 203 participants 402 participants
White 103 102 205
Black 73 79 152
Hispanic 17 18 35
Other 6 4 10
[1]
Measure Description: Race or ethnic group was self-reported.
Asthma medication use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 199 participants 203 participants 402 participants
Inhaled corticosteroids 50 44 94
Combination of fluticasone and salmeterol 149 159 308
Body-mass index >=30   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 199 participants 203 participants 402 participants
BMI >=30 107 102 209
BMI <30 92 101 193
[1]
Measure Description: The body-mass index is the weight in kilograms divided by the square of the height in meters.
Conditions other than asthma   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 199 participants 203 participants 402 participants
Gastroesophageal reflux disease 38 21 59
No GER reported 161 182 343
[1]
Measure Description: These conditions were self-reported.
Former smoker  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 199 participants 203 participants 402 participants
Former Smoker 40 31 71
Never smoked 159 172 331
Health Care Visits   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 199 participants 203 participants 402 participants
Health care visit for asthma exacerbation 126 109 235
No visit 73 94 167
[1]
Measure Description: Unscheduled health care visit for asthma in previous year
Pulmonary function  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 199 participants 203 participants 402 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   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 199 participants 203 participants 402 participants
Positive result 62 61 123
Negative result 89 92 181
Missing result 48 50 98
[1]
Measure Description: 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.
%Predicted amount of air expired in the first second during a forced expiration pre broncho-dilator   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 199 participants 203 participants 402 participants
78  (15) 76  (16) 77  (16)
[1]
Measure Description: 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.
Age of onset of asthma  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 199 participants 203 participants 402 participants
17  (17) 17  (16) 17  (16)
Age of participants  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 199 participants 203 participants 402 participants
at randomization 42  (13) 42  (13) 42  (13)
at onset of asthma 17  (17) 17  (16) 17  (16)
Asthma scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 199 participants 203 participants 402 participants
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)
[1]
Measure Description: 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.
Percent change in FEV1 after bronchodilator   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent change
Number Analyzed 199 participants 203 participants 402 participants
10  (10) 11  (16) 11  (13)
[1]
Measure Description: The percent difference in FEV1 before and after using a bronchodilator (albuterol) divided by the value before bronchodilation.
1.Primary Outcome
Title Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description:
40 mg of placebo twice daily
40 mg of esomeprazole twice daily
Overall Number of Participants Analyzed 193 200
Measure Type: Number
Unit of Measure: events per person year
2.3 2.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Esomeprazole
Comments The rates of EPACs were compared using incidence-rate ratios (IRR). IRR and P value were estimated with the use of negative binomial regression models with robust variance estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments P values are for the treatment effect of esomeprazole as compared with placebo.
Method Negative binomial regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence-Rate Ratio
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.8 to 1.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Exacerbation Components: >=30% Drop in Peak Expiratory Flow on 2 Consecutive Days
Hide Description [Not Specified]
Time Frame Baseline to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description:
40 mg of placebo twice daily
40 mg of esomeprazole twice daily
Overall Number of Participants Analyzed 193 200
Measure Type: Number
Unit of Measure: events per person-year
1.7 2.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Esomeprazole
Comments Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments P values are for the treatment effect of esomeprazole as compared with placebo.
Method Negative binomial regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence-Rate Ratio
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.8 to 2.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Exacerbation Components: Urgent Care Visit
Hide Description [Not Specified]
Time Frame Measured at Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description:
40 mg of placebo twice daily
40 mg of esomeprazole twice daily
Overall Number of Participants Analyzed 193 200
Measure Type: Number
Unit of Measure: events per person-year
0.6 0.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Esomeprazole
Comments Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments P values are for the treatment effect of esomeprazole as compared with placebo.
Method Negative binomial regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence-Rate Ratio
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.6 to 1.5
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Exacerbation Components: New Use of Oral Corticosteroids
Hide Description [Not Specified]
Time Frame Baseline to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description:
40 mg of placebo twice daily
40 mg of esomeprazole twice daily
Overall Number of Participants Analyzed 193 200
Measure Type: Number
Unit of Measure: events per person year
0.6 0.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Esomeprazole
Comments Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments P values are for the treatment effect of esomeprazole as compared with placebo.
Method Negative binomial regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence-Rate Ratio
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.6 to 1.3
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Asthma Episodes, According to Definition That Included Increased Use of Beta-agonists
Hide Description [Not Specified]
Time Frame Baseline to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description:
40 mg of placebo twice daily
40 mg of esomeprazole twice daily
Overall Number of Participants Analyzed 193 200
Measure Type: Number
Unit of Measure: events per person-year
4.4 4.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Esomeprazole
Comments Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments P values are for the treatment effect of esomeprazole as compared with placebo.
Method Negative binomial regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence-Rate Ratio
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.8 to 1.3
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Use of Rescue Medications
Hide Description Increase in the use of rescue meds by 4 or more uses on a particular day above the average uses during the run-in period.
Time Frame Baseline to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description:
40 mg of placebo twice daily
40 mg of esomeprazole twice daily
Overall Number of Participants Analyzed 193 200
Measure Type: Number
Unit of Measure: events per person-year
3.0 2.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Esomeprazole
Comments Incidence-rate ratios and P values were estimated with the use of negative binomial regression models with robust variance estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments P values are for the treatment effect of esomeprazole as compared with placebo.
Method Negative binomial regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence-Rate Ratio
Estimated Value 0.9
Confidence Interval 95%
0.7 to 1.3
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Night Awakening
Hide Description Rate of awakening at night because of asthma symptoms
Time Frame Baseline to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description:
40 mg of placebo twice daily
40 mg of esomeprazole twice daily
Overall Number of Participants Analyzed 193 200
Measure Type: Number
Unit of Measure: events per person-year
30 28
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Esomeprazole
Comments Incidence-rate ratios and P values were estimated with the use of negative binomial regression models with robust variance estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments P values are for the treatment effect of esomeprazole as compared with placebo.
Method Negative binomial regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence-Rate Ratio
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.6 to 1.4
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Pulmonary Function: Change in Prebronchodilator FEV1
Hide Description Mean change in pre-bronchodilator 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
Hide Outcome Measure Data
Hide Analysis Population Description
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% post-diluent baseline (PC20).
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description:
40 mg of placebo twice daily
40 mg of esomeprazole twice daily
Overall Number of Participants Analyzed 191 201
Mean (95% Confidence Interval)
Unit of Measure: liters
-0.02
(-0.06 to 0.01)
0.00
(-0.04 to 0.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Esomeprazole
Comments The treatment effect is the mean change in the Esomeprazole group - mean change in placebo group
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments P values were calculated with the use of linear regression.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.03 to 0.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.03
Estimation Comments 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 Outcome
Title Pulmonary Function: Change in Prebronchodilator Forced Vital Capacity
Hide Description Pulmonary function measured by mean change in Prebronchodilator forced vital capacity from baseline to 24 weeks
Time Frame Baseline to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description:
40 mg of placebo twice daily
40 mg of esomeprazole twice daily
Overall Number of Participants Analyzed 191 201
Mean (95% Confidence Interval)
Unit of Measure: liters
-0.03
(-0.06 to 0.01)
0.00
(-0.04 to 0.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Esomeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.03 to 0.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.03
Estimation Comments Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group
10.Secondary Outcome
Title Pulmonary Function: Change in Peak Flow Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description:
40 mg of placebo twice daily
40 mg of esomeprazole twice daily
Overall Number of Participants Analyzed 191 201
Mean (95% Confidence Interval)
Unit of Measure: liters/min
3.2
(-3.5 to 9.9)
9.2
(1.8 to 16.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Esomeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.0
Confidence Interval (2-Sided) 95%
-4.0 to 16.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.1
Estimation Comments Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group
11.Secondary Outcome
Title Pulmonary Function: Change in PC20
Hide Description Mean Change in the dose of methacholine that results in a 20% drop in FEV1
Time Frame Baseline to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description:
40 mg of placebo twice daily
40 mg of esomeprazole twice daily
Overall Number of Participants Analyzed 41 37
Mean (95% Confidence Interval)
Unit of Measure: mg/ml
1.5
(0.2 to 2.9)
0.3
(-1.4 to 0.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Esomeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Effect
Estimated Value -1.8
Confidence Interval 95%
-3.6 to -0.1
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change in Juniper Asthma Control Score(JACQ)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description:
40 mg of placebo twice daily
40 mg of esomeprazole twice daily
Overall Number of Participants Analyzed 191 201
Mean (95% Confidence Interval)
Unit of Measure: score
-0.3
(-0.4 to -0.2)
-0.2
(-0.3 to -0.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Esomeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Effect
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
0.0 to 0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group
13.Secondary Outcome
Title Change in Asthma Symptom Utility Index (ASUI)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description:
40 mg of placebo twice daily
40 mg of esomeprazole twice daily
Overall Number of Participants Analyzed 191 201
Mean (95% Confidence Interval)
Unit of Measure: score
0.05
(0.03 to 0.07)
0.02
(0.01 to 0.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Esomeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.05 to -0.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.01
Estimation Comments Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group
14.Secondary Outcome
Title Change in the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description:
40 mg of placebo twice daily
40 mg of esomeprazole twice daily
Overall Number of Participants Analyzed 191 201
Mean (95% Confidence Interval)
Unit of Measure: score
0.3
(0.2 to 0.4)
0.3
(0.2 to 0.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Esomeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.2 to 0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group
15.Secondary Outcome
Title Change in Medical Outcomes Study Short-Form 36 Score Quality of Life Score: Physical Component
Hide Description Mean change. Scores on the Medical Outcomes Study Short-Form 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description:
40 mg of placebo twice daily
40 mg of esomeprazole twice daily
Overall Number of Participants Analyzed 191 201
Mean (95% Confidence Interval)
Unit of Measure: score
2.0
(1.1 to 2.9)
1.1
(0.3 to 1.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Esomeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-2.0 to 0.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.6
Estimation Comments Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group
16.Secondary Outcome
Title Change in Medical Outcomes Study Short-Form 36 Quality of Life Score: Mental Component
Hide Description Mean change. Scores on the Medical Outcomes Study Short-Form 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description:
40 mg of placebo twice daily
40 mg of esomeprazole twice daily
Overall Number of Participants Analyzed 191 201
Mean (95% Confidence Interval)
Unit of Measure: score
0.0
(-1.8 to 1.1)
0.4
(-0.5 to 1.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Esomeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-1.1 to 2.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.78
Estimation Comments Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group
17.Secondary Outcome
Title Change in Gastric Symptoms: Gastroesophageal Reflux Disease Symptom Assessment Scale Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description:
40 mg of placebo twice daily
40 mg of esomeprazole twice daily
Overall Number of Participants Analyzed 191 201
Mean (95% Confidence Interval)
Unit of Measure: score
-0.17
(-0.21 to -0.12)
-0.16
(-0.20 to -0.11)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Esomeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.05 to 0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.03
Estimation Comments Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group
18.Secondary Outcome
Title Change in Number of Gastric Symptoms: No. of Symptoms
Hide Description Mean change
Time Frame Baseline to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description:
40 mg of placebo twice daily
40 mg of esomeprazole twice daily
Overall Number of Participants Analyzed 191 201
Mean (95% Confidence Interval)
Unit of Measure: symptoms
-1.7
(-2.1 to -1.3)
-1.9
(-2.3 to -1.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Esomeprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.8 to 0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.3
Estimation Comments Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Esomeprazole
Hide Arm/Group Description 40 mg of placebo twice daily 40 mg of esomeprazole twice daily
All-Cause Mortality
Placebo Esomeprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Placebo Esomeprazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/199 (8.04%)      10/203 (4.93%)    
Cardiac disorders     
Hospitalization for possible cardiac ischemia   2/193 (1.04%)  2 0/203 (0.00%)  0
General disorders     
Hospitalization or emergency department visit for surgery, trauma, or other acute illness *  9/193 (4.66%)  10 5/203 (2.46%)  6
Pregnancy, puerperium and perinatal conditions     
Pregnancy   1/143 (0.70%)  1 0/130 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma exacerbation requiring hospitalization *  4/193 (2.07%)  4 3/203 (1.48%)  3
Pneumonia   0/193 (0.00%)  0 1/203 (0.49%)  1
Death from complications after surgery for endobronchial tumor *  0/193 (0.00%)  0 1/203 (0.49%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Esomeprazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/199 (0.00%)      0/203 (0.00%)    
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ellen Brown
Organization: Johns Hopkins University
Phone: 443-287-3170
EMail: ala-acrc@jhsph.edu
Layout table for additonal information
Responsible Party: Robert Wise, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00069823    
Other Study ID Numbers: 157
U01HL072968 ( U.S. NIH Grant/Contract )
First Submitted: October 1, 2003
First Posted: October 3, 2003
Results First Submitted: May 14, 2010
Results First Posted: October 19, 2012
Last Update Posted: December 19, 2012