A Randomized, Double-Blind, Placebo-Controlled Study of Gastroesophageal Reflux Disease Therapy.
Status unconfirmed · Phase 4
Conditions studied: Asthma
In brief
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.
Key facts
- Study ID
- NCT00237068
- Run by
- Emory University
- People needed
- 100
- Starts
- 2006-03-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2011-03-16
Who can join
Age: 4 and older, up to 11. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 4-11 years Informed Consent/ Assent Asthma Clinically normal laboratory results and physical exam
You may not qualify if…
- 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.
Where it is running
- Emory Children's Center — Atlanta, Georgia, United States
- Children's Center for Digestive Healthcare — Atlanta, Georgia, United States
- Georgia Pediatric Pulmonology Associates/ CHOA — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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