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Lansoprazole to Treat Children With Asthma (SARCA)

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ClinicalTrials.gov Identifier: NCT00442013
Recruitment Status : Completed
First Posted : March 1, 2007
Results First Posted : December 6, 2012
Last Update Posted : December 6, 2012
American Lung Association Asthma Clinical Research Centers
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Janet Holbrook, Johns Hopkins University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Lansoprazole
Drug: Matching placebo

  Participant Flow

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
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

  Outcome Measures

1.  Primary:   Change in Juniper Asthma Control Score (ACS)   [ Time Frame: Measured at Weeks 0, 4, 8, 12, 24 ]

2.  Secondary:   Asthma-specific Quality of Life   [ Time Frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24 ]

3.  Secondary:   Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24 ]

4.  Secondary:   Rate of Episodes of Poor Asthma Control (EPAC)   [ Time Frame: Measured daily for 24 weeks by diary ]

5.  Secondary:   Asthma Symptom Utility Index (ASUI)   [ Time Frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24 ]

6.  Secondary:   Airways Reactivity (Assessed by Methacholine PC20)   [ Time Frame: Measured at Weeks 0 and 24 ]

  Serious Adverse Events

  Other Adverse Events

  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.

  More Information