A Randomized, Double-Blind, Placebo-Controlled Study of Gastroesophageal Reflux Disease Therapy.
Status:
Unknown status
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
Summary
Asthma and gastroesophageal reflux disease (GERD) are common disorders, which although are
not usually lethal, both have high morbidity, and high healthcare costs. Recent studies have
demonstrated that asthma and GERD often co-exists, and that this co-existence is more
frequent than just chance. Therefore, studies that characterize associations between these
conditions, and, help in the development of interventions will positively impact the outcomes
of these patients, which are critically needed.
Subjects that participate in this study are required to be between the ages of 4-11 years
old. This protocol proposes to enroll 100 children with asthma, on inhaled steroids who have
poor asthma control, defined on the basis of frequent symptoms, excessive beta-agonists use,
or frequent asthma episodes.
The purpose of this research study is to:
1. Determine, whether children with symptomatic, poorly controlled, asthma assigned to
treatment with a PPI( Proton Pump Inhibitor), have fewer asthma exacerbations than
similar participants assigned to placebo for a similar duration of time
2. Determine whether children treated with Lansoprazole ( i.e., proton pump inhibitor):
have a longer time to first exacerbation, have improved lung function, improved asthma
symptom scores, improved quality of life, decreased rescue inhaler use, or other asthma
medications, reduced emergency room/urgent care/ physician office visits that are asthma
related.
3. Determine whether a subgroup of symptomatic asthmatics, who show a greater benefit from
PPI's, can be identified.