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Lansoprazole to Treat Children With Asthma (SARCA)

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):
Janet Holbrook, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00442013
First received: February 28, 2007
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
Results First Received: July 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Lansoprazole
Drug: Matching 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
Conducted from April 2007 to April 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lansoprazole Group 15 mg/day by mouth for children weighing less than 30kg, one tablet per day in the evening before a meal 30 mg/day by mouth for children weighing 30 kg or more, two tablets per day in the evening before a meal
Placebo Group Matching placebo with no active ingredients. Either 1 or 2 tablets per day, depending on weight, in the evening before a meal

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



  Baseline Characteristics
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Reporting Groups
  Description
Lansoprazole Group 15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
Placebo Group Matching placebo
Total Total of all reporting groups

Baseline Measures
    Lansoprazole Group     Placebo Group     Total  
Number of Participants  
[units: participants]
 		  157     149     306  
Age  
[units: participants]
 		     
<=18 years     157     149     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     55     63     118  
Male     102     86     188  
Region of Enrollment  
[units: participants]
 		     
United States     157     149     306  



  Outcome Measures
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1.  Primary:   Change in Juniper Asthma Control Score (ACS)   [ Time Frame: Measured at Weeks 0, 4, 8, 12, 24 ]
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2.  Secondary:   Asthma-specific Quality of Life   [ Time Frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24 ]
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3.  Secondary:   Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24 ]
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4.  Secondary:   Rate of Episodes of Poor Asthma Control (EPAC)   [ Time Frame: Measured daily for 24 weeks by diary ]
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5.  Secondary:   Asthma Symptom Utility Index (ASUI)   [ Time Frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24 ]
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6.  Secondary:   Airways Reactivity (Assessed by Methacholine PC20)   [ Time Frame: Measured at Weeks 0 and 24 ]
  Show Outcome Measure 6


  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
Results limited to patients without overt Gastroesophageal reflux disease(GERD). Did not conduct on-treatment potential hydrogen(pH) probe studies to confirm treatment effect. Protein-pump inhibitors(PPI) dose may not induce maximal acid suppression.  


Results Point of Contact:  
Name/Title: Janet Holbrook
Organization: Johns Hopkins University
phone: 443-287-3170
e-mail: ala-acrc@jhsph.edu


Publications of Results:

Publications automatically indexed to this study:


Responsible Party: Janet Holbrook, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00442013     History of Changes
Other Study ID Numbers: 454, U01HL080450-01
Study First Received: February 28, 2007
Results First Received: July 23, 2012
Last Updated: December 5, 2012
Health Authority: United States: Federal Government