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.
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 potential Hydrogen (pH) monitor for 24 hours to evaluate GERD symptoms and the relationship between GERD and asthma symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
306
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.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Change in Juniper Asthma Control Score (ACS)
Score ranges from 0 to 6, a lower score indicated better asthma control. Scores above 1.5 are indicative of poor asthma control; score obtained from questionnaire with 6 questions related to asthma control and FEV (amount of air expired in the first second during a forced expiratory maneuver); number presents an average of the change from baseline to all follow-up points
Time frame: Measured at Weeks 0, 4, 8, 12, 24
Asthma-specific Quality of Life
Scores range from 1 to 7 with higher values indicating better asthma-related quality of life; questionnaire measures functional impairments that are most troublesome to children as a result of their asthma; number presents an average of the change from baseline to all follow-up points
Time frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24
Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
A measure of pulmonary function, specifically the amount of expired air in the first second during a forced expiratory maneuver while seated; test performed at least 4 hours after last dose of short-acting bronchodilator and at least 12 hours after long-acting bronchodilator; number presents an average of the change from baseline to all follow-up points
Time frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24
Rate of Episodes of Poor Asthma Control (EPAC)
Episodes of poor asthma control are defined as any one of the following: * 2 consecutive days with peak flow at less than 70% of baseline * prescription of oral corticosteroids for asthma * seeking urgent medical care for asthma symptoms EPAC was measured by review of daily diaries that were maintained over the entire course of followup, i.e, 24 weeks
Time frame: Measured daily for 24 weeks by diary
Asthma Symptom Utility Index (ASUI)
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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
...and 10 more locations
ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms; number presents an average of the change from baseline to all follow-up points
Time frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24
Airways Reactivity (Assessed by Methacholine PC20)
Presence and degree of airway hyperresponsiveness; change from baseline to 24 weeks for airways reactivity assessed by methacholine post-diluent baseline (PC20) after medication holds
Time frame: Measured at Weeks 0 and 24