Lansoprazole to Treat Children With Asthma

Approximately 75% of individuals with asthma also experience GERD. If left untreated, GERD
can lead to lung damage, esophageal ulcers, or esophageal cancer. Children and adults whose
asthma is poorly controlled with inhaled corticosteroids are often prescribed drugs that
suppress gastric acid production; however, this treatment is expensive and has not been
proven beneficial. Lansoprazole is a proton pump inhibitor medication that reduces stomach
acid production. It may also decrease the frequency of asthma exacerbations in children with
poorly controlled asthma. The purpose of this study is to evaluate the effectiveness of
lansoprazole at improving asthma control, quality of life, and lung function in children
with asthma.

This study will enroll children with poor asthma control who are receiving inhaled
corticosteroids. Participants will be randomly assigned to receive either lansoprazole or
placebo on a daily basis for 6 months. Study visits will occur at baseline and Weeks 4, 8,
12, 16, 20, and 24, and participants will be contacted by telephone at Week 2. A physical
examination, blood collection, and methacholine challenge test will occur at selected
visits. The methacholine challenge test will be used to help determine the severity of an
individual's asthma. Lung function and airway pressure testing, questionnaires on asthma
control and quality of life, medical history review, pill counts, and distribution of
medication will occur at most study visits. Participants will record asthma symptoms and
lung function in a daily diary throughout the study. A select group of participants will
also wear an esophageal pH monitor for 24 hours to evaluate GERD symptoms and the
relationship between GERD and asthma symptoms.