Study of Acid Reflux in Asthma
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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
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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
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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.
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Baseline Characteristics
Arm/Group Title | Placebo | Esomeprazole | Total | |
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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 | |
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[Not Specified]
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 199 participants | 203 participants | 402 participants | |
Female |
143 71.9%
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130 64.0%
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273 67.9%
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Male |
56 28.1%
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73 36.0%
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129 32.1%
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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.
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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.
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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.
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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
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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.
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%Predicted amount of air expired in the first second during a forced expiration pre broncho-dilator
[1] Mean (Standard Deviation) Unit of measure: Percent |
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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.
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Age of onset of asthma
Mean (Standard Deviation) Unit of measure: Years |
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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.
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Percent change in FEV1 after bronchodilator
[1] Mean (Standard Deviation) Unit of measure: Percent change |
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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.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Ellen Brown |
Organization: | Johns Hopkins University |
Phone: | 443-287-3170 |
EMail: | ala-acrc@jhsph.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |