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 50 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 episodes 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.

Condition	Intervention	Phase
Asthma	Drug: Lansoprazole; Solutab	Phase IV

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcomes: One of the aims of this trial is to see if we can demonstrate a significant response to acid-suppression therapy in a group of poorly controlled childhood asthmatics using the number of asthma exacerbations as outcome variables.
Secondary Outcomes: A major unanswered question is whether severity or frequency of asthma is related to the response to anti-reflux treatment.
Expected Total Enrollment:  50

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 “…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” 16-18. The American Thoracic Society (ATS) workshop on severe refractory asthma, concluded that GERD “…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” 19. 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 21, 22. 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 23, 24. 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 10. Therefore, randomized controlled clinical trials are critically needed to reduce overall healthcare costs and the public health burden of these two chronic conditions.

Ages Eligible for Study:  4 Years   -   11 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00237068

Benjamin D Gold, MD.      404-727-1463    ben_gold@oz.ped.emory.edu
Kimberly L Balark, RN, MSN      404-727-9831    kimberly_balark@oz.ped.emory.edu

Georgia
      Emory Children''''s Center, Atlanta,  Georgia,  30322,  United States
      Georgia Pediatric Pulmonology Associates/ CHOA, Atlanta,  Georgia,  30342,  United States

Study chairs or principal investigators

Benjamin D. Gold, MD.,  Principal Investigator,  Emory University School of Medicine / Pediatrics   

Study ID Numbers:  GERD AsthmaStudy
Last Updated:  December 8, 2005
Record first received:  October 11, 2005
ClinicalTrials.gov Identifier:  NCT00237068
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10