Intervention: Lansoprazole
Trial phase: Phase 4
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 149
Group description: 15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
Eligibility criteria:
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