The Study of Acid Reflux in Children with Asthma (SARCA) was a randomized (allocation ratio 1:1) double masked, placebo-controlled, parallel clinical trial designed to evaluate the effectiveness of lansoprazole (Prevacid ®, TAKEDA Pharmaceuticals North America) for treatment of asthma in children (clinicaltrial.gov NCT00442013). The study was conducted at 19 American Lung Association's Asthma Clinical Research Center (ALA-ACRC) sites from to April 2007 to April 2011. The study was approved by the institutional review board at each center, and the legal guardians signed informed consent statement and the participants signed assent statement according to local regulatory policy.
Children were randomly assigned to receive either lansoprazole (15 mg daily for children < 30 kg; 30 mg daily for children ≥ 30 kg) or a matching placebo. A permuted block treatment assignment schedule stratified by clinical center was used. Treatment assignments were masked throughout the study. After the screening and randomization visits, participants returned to the clinical centers for assessments every 4 weeks for 24 weeks. Throughout the study children kept daily diaries to record morning peak expiratory flow, asthma symptoms, nocturnal awakenings, use of short-acting β-agonists (excluding routine use before exercise), oral corticosteroid use, and unscheduled health care visits for asthma symptoms. Ambulatory esophageal pH monitoring prior to randomization was conducted in a subgroup of children who agreed to the procedure at 13 clinical centers with the capability of doing pH probe studies for the study. Participants were paid, on average, ($ ) for each study visit.
Children were randomly assigned to receive either lansoprazole (15 mg daily for children < 30 kg; 30 mg daily for children ≥ 30 kg) or a matching placebo. A permuted block treatment assignment schedule stratified by clinical center was used. Treatment assignments were masked throughout the study. After the screening and randomization visits, participants returned to the clinical centers for assessments every 4 weeks for 24 weeks. Throughout the study children kept daily diaries to record morning peak expiratory flow, asthma symptoms, nocturnal awakenings, use of short-acting β-agonists (excluding routine use before exercise), oral corticosteroid use, and unscheduled health care visits for asthma symptoms. Ambulatory esophageal pH monitoring prior to randomization was conducted in a subgroup of children who agreed to the procedure at 13 clinical centers with the capability of doing pH probe studies for the study. Participants were paid, on average, ($ ) for each study visit.
