Lansoprazole to Treat Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Lansoprazole; Matching placebo
Intervention description: Participants less than 30 kg will receive 15 mg a day, by mouth; participants greater than or equal to 30 kg will receive 30 mg a day, by mouth.; Participants will receive a placebo pill on a daily basis. To maintain masking, there are two doses of the matching placebo provided to participants depending on participant body weight at randomization: 1.) less than 30kg will receive 15mg po once daily or 2.)greater or equal to 30kg 30mg po once daily.
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 306.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Many individuals with asthma also experience gastroesophageal reflux disease (GERD), a
      condition in which excess stomach acid flows backwards into the esophagus. This study will
      evaluate the effectiveness of lansoprazole, a medication commonly used to treat GERD in
      improving asthma control and reducing symptoms in children with poorly controlled asthma.
    

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:

               1. 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

               2. Methacholine post-diluent baseline (PC20) less than 16 mg/ml, or

               3. 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:

               1. Use of beta-agonist for asthma symptoms twice a week or more on average in the
                  month prior to study entry

               2. Nocturnal awakening with asthma symptoms more than once per week on average in
                  the month prior to study entry

               3. Two or more emergency department visits, unscheduled physician visits, prednisone
                  courses, or hospitalizations for asthma in the 12 months prior to study entry

               4. 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