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Study of Acid Reflux in Asthma

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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The planned enrollment was for 400 participants, 403 participants actually were enrolled and randomized in the trial. It is not uncommon for clinical trials not to exactly meet the sample size stated in the protocol.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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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  Outcome Measures
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1.  Primary:   Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion   [ Time Frame: Baseline to 24 Weeks ]
  Show Outcome Measure 1

2.  Secondary:   Exacerbation Components: >=30% Drop in Peak Expiratory Flow on 2 Consecutive Days   [ Time Frame: Baseline to 24 Weeks ]
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3.  Secondary:   Exacerbation Components: Urgent Care Visit   [ Time Frame: Measured at Month 6 ]
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4.  Secondary:   Exacerbation Components: New Use of Oral Corticosteroids   [ Time Frame: Baseline to 24 Weeks ]
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5.  Secondary:   Asthma Episodes, According to Definition That Included Increased Use of Beta-agonists   [ Time Frame: Baseline to 24 Weeks ]
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6.  Secondary:   Use of Rescue Medications   [ Time Frame: Baseline to 24 Weeks ]
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7.  Secondary:   Night Awakening   [ Time Frame: Baseline to 24 Weeks ]
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8.  Secondary:   Pulmonary Function: Change in Prebronchodilator FEV1   [ Time Frame: Baseline to 24 Weeks ]
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9.  Secondary:   Pulmonary Function: Change in Prebronchodilator Forced Vital Capacity   [ Time Frame: Baseline to 24 Weeks ]
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10.  Secondary:   Pulmonary Function: Change in Peak Flow Rate   [ Time Frame: Baseline to 24 Weeks ]
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11.  Secondary:   Pulmonary Function: Change in PC20   [ Time Frame: Baseline to 24 Weeks ]
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12.  Secondary:   Change in Juniper Asthma Control Score(JACQ)   [ Time Frame: Baseline to 24 Weeks ]
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13.  Secondary:   Change in Asthma Symptom Utility Index (ASUI)   [ Time Frame: Baseline to 24 Weeks ]
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14.  Secondary:   Change in the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ)   [ Time Frame: Baseline to 24 Weeks ]
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15.  Secondary:   Change in Medical Outcomes Study Short-Form 36 Score Quality of Life Score: Physical Component   [ Time Frame: Baseline to 24 Weeks ]
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16.  Secondary:   Change in Medical Outcomes Study Short-Form 36 Quality of Life Score: Mental Component   [ Time Frame: Baseline to 24 Weeks ]
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17.  Secondary:   Change in Gastric Symptoms: Gastroesophageal Reflux Disease Symptom Assessment Scale Score   [ Time Frame: Baseline to 24 Weeks ]
  Show Outcome Measure 17

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


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Ellen Brown
Organization: Johns Hopkins University
phone: 443-287-3170
e-mail: ala-acrc@jhsph.edu


No publications provided by Johns Hopkins Bloomberg School of Public Health

Publications automatically indexed to this study:


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