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Study of Acid Reflux in Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00069823
First Posted: October 3, 2003
Last Update Posted: December 19, 2012
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.
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
Results First Submitted: 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
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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
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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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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 
[1] Race or ethnic group was self-reported.
Asthma medication use 
[Units: Participants]
 		     
Inhaled corticosteroids   50   44   94 
Combination of fluticasone and salmeterol   149   159   308 
Body-mass index >=30 [1] 
[Units: Participants]
 		     
BMI >=30   107   102   209 
BMI <30   92   101   193 
[1] The body-mass index is the weight in kilograms divided by the square of the height in meters.
Conditions other than asthma [1] 
[Units: Participants]
 		     
Gastroesophageal reflux disease   38   21   59 
No GER reported   161   182   343 
[1] These conditions were self-reported.
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 
[1] Unscheduled health care visit for asthma in previous year
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 [1] 
[Units: Participants]
 		     
Positive result   62   61   123 
Negative result   89   92   181 
Missing result   48   50   98 
[1] 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] 
[Units: Percent]
Mean (Standard Deviation) 		 78  (15)   76  (16)   77  (16) 
[1] 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 
[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) 
[1] 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] 
[Units: Percent change]
Mean (Standard Deviation) 		 10  (10)   11  (16)   11  (13) 
[1] The percent difference in FEV1 before and after using a bronchodilator (albuterol) divided by the value before bronchodilation.


  Outcome Measures
  Show All Outcome Measures

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 ]
  Show Outcome Measure 2

3.  Secondary:   Exacerbation Components: Urgent Care Visit   [ Time Frame: Measured at Month 6 ]
  Show Outcome Measure 3

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 ]
  Show Outcome Measure 5

6.  Secondary:   Use of Rescue Medications   [ Time Frame: Baseline to 24 Weeks ]
  Show Outcome Measure 6

7.  Secondary:   Night Awakening   [ Time Frame: Baseline to 24 Weeks ]
  Show Outcome Measure 7

8.  Secondary:   Pulmonary Function: Change in Prebronchodilator FEV1   [ Time Frame: Baseline to 24 Weeks ]
  Show Outcome Measure 8

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 ]
  Show Outcome Measure 14

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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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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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.


Results Point of Contact:  
Name/Title: Ellen Brown
Organization: Johns Hopkins University
phone: 443-287-3170
e-mail: 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     History of Changes
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



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