Study of Acid Reflux Therapy for Children With Asthma (SARCA)

This study has been completed.
Sponsor:
Collaborators:
American Lung Association
Johns Hopkins University
Nemours Children's Clinic
University of Manitoba
Washington University School of Medicine
New York Medical College
University of Vermont
Ohio State University
Baylor College of Medicine
Duke University
Information provided by (Responsible Party):
Anne M Fitzpatrick PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00604851
First received: December 27, 2007
Last updated: January 14, 2014
Last verified: January 2014
Results First Received: July 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: lansoprazole
Drug: placebo

  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
Subjects were recruited from medical clinics and community advertisements at the participating organizations.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Children who met eligibility criteria underwent a 4-week screening period to determine whether they met pre-specified criteria for poor asthma control.

Reporting Groups
  Description
Lansoprazole lansoprazole : participants < 30 kg: 15 mg taken by mouth once daily, participants >= 30 kg: 30 mg taken by mouth once daily
Placebo placebo medication, taken by mouth once daily

Participant Flow:   Overall Study
    Lansoprazole     Placebo  
STARTED     149     157  
COMPLETED     132     131  
NOT COMPLETED     17     26  



  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
Lansoprazole lansoprazole : participants < 30 kg: 15 mg po once daily
Placebo placebo : participants < 30 kg: 15 mg po once daily participants <= 30 kg: 30 mg po once daily
Total Total of all reporting groups

Baseline Measures
    Lansoprazole     Placebo     Total  
Number of Participants  
[units: participants]
  149     157     306  
Age  
[units: participants]
     
<=18 years     149     157     306  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  11  ± 3     11  ± 3     11  ± 3  
Gender  
[units: participants]
     
Female     63     55     118  
Male     86     102     188  
Region of Enrollment  
[units: participants]
     
United States     149     157     306  



  Outcome Measures

1.  Primary:   Change in Asthma Control Questionnaire Score at the 24 Week Visit.   [ Time Frame: Baseline and 24 weeks ]

2.  Secondary:   Asthma Symptom and Control Scores   [ Time Frame: Baseline and 24 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   GER Symptoms   [ Time Frame: Baseline and 24 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Lung Function   [ Time Frame: Baseline and 24 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Unscheduled Heathcare Contacts   [ Time Frame: Baseline and 24 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  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: W Gerald Teague
Organization: University of Virginia
phone: 434-243-0613
e-mail: wgt2p@hscmail.mcc.virginia.edu


No publications provided by Emory University

Publications automatically indexed to this study:

Responsible Party: Anne M Fitzpatrick PhD, Emory University
ClinicalTrials.gov Identifier: NCT00604851     History of Changes
Other Study ID Numbers: IRB00001316, 5U01HL080433-02, SARCA
Study First Received: December 27, 2007
Results First Received: July 10, 2013
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board