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Sponsored by: |
Emory University |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00237068 |
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:
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Lansoprazole; Solutab |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Bio-equivalence Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of Gastroesophageal Reflux Disease Therapy ( Lansoprazole; Solutab) in the Management of Childhood Asthma |
Estimated Enrollment: | 50 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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practice patterns among clinics with about 15% of children and 20% - 30% of adults being prescribed medical treatment (unpublished data).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 to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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.
Contact: Benjamin D Gold, MD | 404-727-1463 | ben_gold@oz.ped.emory.edu |
Contact: April C Cameron, MPH | 404-727-1318 | april_cameron@oz.ped.emory.edu |
United States, Georgia | |
Emory Children's Center | Not yet recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Arlene Stecenko, MD 404-778-2400 astecen@emory.edu | |
Contact: April C Cameron, MPH 404-727-1318 april_cameron@oz.ped.emory.edu | |
Sub-Investigator: Arlene Stecenko, MD | |
Principal Investigator: Benjamin D Gold, MD | |
Sub-Investigator: Lisa Kobrynski, MD | |
Sub-Investigator: Karen DeMuth, MD | |
Georgia Pediatric Pulmonology Associates/ CHOA | Not yet recruiting |
Atlanta, Georgia, United States, 30342 | |
Contact: Burton Lesnick, MD 404-252-7339 blesnick@gppa.net | |
Contact: Tanisha Denny, MPH 404-252-7339 ext 1034 Tdenny@gppa.net | |
Sub-Investigator: Burton Lesnick, MD | |
Sub-Investigator: Randall W Brown, MD, MPH | |
Children's Center for Digestive Healthcare | Recruiting |
Atlanta, Georgia, United States, 30342 | |
Contact: Jeffrey D. Lewis, M.D. 404-257-1577 jlewis@ccdhc.org | |
Contact: Tamara Gobin (404) 503-2263 tgobin@ccdhc.org | |
Principal Investigator: Jeffrey D. Lewis, M.D. |
Principal Investigator: | Benjamin D. Gold, MD. | Emory University School of Medicine / Pediatrics |
Responsible Party: | Emory University ( Benjamin Gold, MD ) |
Study ID Numbers: | GERD AsthmaStudy |
Study First Received: | October 11, 2005 |
Last Updated: | August 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00237068 |
Health Authority: | United States: Food and Drug Administration |
Gastroesphageal Reflux |
Esophageal disorder Gastrointestinal Diseases Asthma Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Lung Diseases, Obstructive Hypersensitivity |
Digestive System Diseases Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Lansoprazole Esophageal Diseases Respiratory Hypersensitivity |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Bronchial Diseases Therapeutic Uses |
Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |