A Randomized, Double-Blind, Placebo-Controlled Study of Gastroesophageal Reflux Disease Therapy.

• Status: Unknown status
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University
• Treatments: Dexlansoprazole; Lansoprazole

Criteria

Inclusion Criteria:

4-11 years Informed Consent/ Assent Asthma Clinically normal laboratory results and physical exam

Exclusion Criteria:

Unable or unwilling to give informed consent Unable to comply with study protocol Any preexisting condition that would require A PPI for a period of 6 months or more and/other major chronic illnesses.

Drug Allergies toPPI. At High risk for non-compliance and/or adherence.