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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00237068
Recruitment Status : Unknown
Verified March 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was:  Active, not recruiting
First Posted : October 12, 2005
Last Update Posted : March 16, 2011
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Lansoprazole; Solutab Phase 4

Detailed Description:

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". 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". 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Gastroesophageal Reflux Disease Therapy ( Lansoprazole; Solutab) in the Management of Childhood Asthma
Study Start Date : March 2006
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma GERD

Intervention Details:
  • Drug: Lansoprazole; Solutab
    15 and 30 mg doses of dissolvable tablet, 2 tablets daily for one year
    Other Name: Prevacid

Primary Outcome Measures :
  1. 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. [ Time Frame: 3 year ]

Secondary Outcome Measures :
  1. A major unanswered question is whether severity or frequency of asthma is related to the response to anti-reflux treatment. [ Time Frame: 3 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00237068

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United States, Georgia
Emory Children's Center
Atlanta, Georgia, United States, 30322
Children's Center for Digestive Healthcare
Atlanta, Georgia, United States, 30342
Georgia Pediatric Pulmonology Associates/ CHOA
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Emory University
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Principal Investigator: Benjamin D. Gold, MD. Emory University School of Medicine / Pediatrics

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Responsible Party: Benjamin Gold, MD, Emory University Identifier: NCT00237068     History of Changes
Other Study ID Numbers: GERD AsthmaStudy
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: March 16, 2011
Last Verified: March 2011
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Gastroesophageal Reflux
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action