Lansoprazole to Treat Children With Asthma

Completed · Phase 4 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00442013

Run by

Johns Hopkins University

People needed

306

Starts

2007-03-01

Expected to finish

2011-08-01

Last updated by the study team

2012-12-06

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California San Diego — San Diego, California, United States
• National Jewish Medical and Research Center — Denver, Colorado, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• University of Miami School of Medicine — Miami, Florida, United States
• University of South Florida College of Medicine — Tampa, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• University of Missouri, Kansas City School of Medicine — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• North Shore-Long Island Jewish Health System — New Hyde Park, New York, United States
• New York University School of Medicine — New York, New York, United States
• New York Medical College — Valhalla, New York, United States
• Duke University School of Medicine — Durham, North Carolina, United States
• Davis Heart and Lung Research Institute — Columbus, Ohio, United States
• Penn Presbyterain Medical Center/Penn Lung Center — Philadelphia, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• Vermont Lung Center at The University of Vermont — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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