Lansoprazole to Treat Children With Asthma (SARCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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

  Baseline Characteristics

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.
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Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
 157   149   306 
[Units: Participants]
<=18 years   157   149   306 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 11  (3)   11  (3)   11  (3) 
[Units: Participants]
Female   55   63   118 
Male   102   86   188 
Region of Enrollment 
[Units: Participants]
United States   157   149   306 

  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