Lansoprazole to Treat Children With Asthma

Inclusion Criteria

• Physician-diagnosed asthma
• At least one of the following lung function criteria must be documented in the year prior to study entry:
• Bronchial hyperresponsiveness confirmed by 12% or greater improvement in amount of air expired in first second during a forced expiratory maneuver (FEV1) post-bronchodilator, or
• Methacholine post-diluent baseline (PC20) less than 16 mg/ml, or
• Exercise bronchoprovocation test with at least a 20% decrease in FEV1
• Currently on stable dose of daily inhaled corticosteroid for asthma control (i.e., inhaled corticosteroid equivalent to 2 puffs of 44 ug twice per day [176 ug] of fluticasone or greater for 8 weeks or longer prior to study entry)
• Poor asthma control as defined by any one of the following criteria:
• Use of beta-agonist for asthma symptoms twice a week or more on average in the month prior to study entry
• Nocturnal awakening with asthma symptoms more than once per week on average in the month prior to study entry
• Two or more emergency department visits, unscheduled physician visits, prednisone courses, or hospitalizations for asthma in the 12 months prior to study entry
• Juniper Asthma Control Score (ACS) of 1.25 or greater at the first screening visit
• Absence of GERD symptoms at the time of study entry

Exclusion Criteria

• Previous anti-reflux or peptic ulcer surgery
• Previous tracheoesophageal fistula repair
• FEV1 less than 60% of predicted normal value at screening visit and as measured immediately before methacholine bronchoprovocation; methacholine bronchoprovocation will be limited to participants with a FEV1 greater than or equal to 70% of predicted value in accordance with American Thoracic Society (ATS) guidelines
• History of a premature birth of less than 33 weeks gestation or any neonate requiring a significant level of respiratory care, including mechanical ventilation
• Any major chronic illness, including but not limited to non-skin cancer, cystic fibrosis, bronchiectasis, myelomeningocele, sickle cell anemia, endocrine disease, congenital heart disease, congestive heart failure, stroke, severe hypertension, insulin-dependent diabetes mellitus, kidney failure, liver disorder, immunodeficiency state, significant neuro-developmental delay or behavioral disorder (excluding mild attention deficit hyperactivity disorder), or other condition that would interfere with participation in the study
• History of phenylketonuria
• Medications for treatment of GI symptoms (e.g., proton pump inhibitors, H2 blockers, bethanechol, metoclopramide) in the month prior to study entry (intermittent anti-acids are allowed)
• Use of theophylline preparations, azoles, anti-coagulants, insulin for Type I diabetes, digitalis, or oral iron supplements when administered for iron deficiency in the month prior to study entry
• Use of any investigative drug in the 2 months prior to study entry
• Previous adverse effects from lansoprazole, other proton pump inhibitors, or sensitivity to aspartame
• Inability or unwillingness of the legal guardian to provide consent
• Inability or unwillingness of the child to provide assent
• Inability to take study medication
• Inability to perform baseline measurements
• Less than 80% completion of screening period diaries
• Inability to contact by telephone
• Planning to move out of the area in the 6 months following study entry
• Pregnancy