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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
National Heart, Lung, and Blood Institute (NHLBI)
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 
Overall Participants Analyzed 
[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


  More Information