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

Status:	Archived
Conditions:	Asthma, Gastroesophageal Reflux Disease
Therapuetic Areas:	Gastroenterology, Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	Any
Updated:	7/1/2011

A Randomized, Double-Blind, Placebo-Controlled Study of Gastroesophageal Reflux Disease Therapy ( Lansoprazole; Solutab) in the Management of Childhood Asthma

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.

GERD and asthma likely co-exist, and may be pathogenetically linked. However, it is
controversial whether GERD per se is an important risk factor for severe asthma, and whether
treatment of GERD and/or GERD symptoms improves asthma control. In addition, there are no
published data on how often asthmatics are treated with the anti-secretory agents proton
pump inhibitors (PPIs) for GERD. However, a preliminary survey from the American Lung
Association's Asthma Clinical Research Centers consortium show diverse practice patterns
among clinics with about 15% of children and 20% - 30% of adults being prescribed medical
treatment (unpublished data).

The NIH Expert Panel on The Diagnosis and Management of Asthma, recommends that "â€¦for
patients with poorly controlled asthma, particularly with a nocturnal component,
investigation for gastroesophageal reflux may be warranted even in the absence of suggestive
symptoms". The American Thoracic Society (ATS) workshop on severe refractory asthma,
concluded that GERD "â€¦could contribute to the severity" of asthma and recommended that all
patients with severe refractory asthma undergo esophageal pH probe monitoring to evaluate
for the presence of GERD". Noticeably absent in both of these "expert panel" documents were
randomized placebo controlled trial data in all populations, and properly designed clinical
trial information in the pediatric population with clear case and control definitions of
GERD and asthma. The American Gastroenterological Association recommends ambulatory pH
probe monitoring in adult patients with reflux-triggered asthma; but, to date has developed
no recommendations for children 20. While these are reasonable recommendations, there is no
convincing evidence that GERD is more common in patients with severe asthma than mild
asthma, or that treatment of reflux can decrease asthma severity. PPIs, the most effective
treatment for GERD (i.e., resolve both symptoms and mucosal disease), have a retail cost
between $100 and $153 per month. However, recent hospital data demonstrates that
anti-reflux surgery is being performed at an increasing rate in children with respiratory
manifestations of their GERD at a sizeable cost and with no long term outcome studies to
date. Thus, it can be estimated that the cost for diagnosing and treating GERD in
symptomatic asthmatics ranges from $1 to $8 billion dollars per year if all poorly
controlled asthmatics were both investigated and treated. Therefore, randomized controlled
clinical trials are critically needed to reduce overall healthcare costs and the public
health burden of these two chronic conditions.

We found this trial at

sites

Children's Center for Digestive Healthcare

Atlanta, Georgia 30342

from

Atlanta, GA