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Sponsors and Collaborators: |
Emory University American Lung Association Johns Hopkins University Nemours Children's Clinic University of Manitoba Washington University School of Medicine New York Medical College University of Vermont Ohio State University Baylor College of Medicine Duke University |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00604851 |
Gastroesophageal reflux (GER) is frequent in children with asthma, can induce bronchspasm, and increase airway reactivity. Children with asthma are often treated for GER with drugs to supress gastric acid production. However, this treatment is expensive, and with unproven benefit. The primary objective of this study is to conduct a multi-site, randomized, clinical trial to test the hypothesis that treatment of GER with lansoprazole, an approved proton pump inhibitor, will decrease the frequency of exacerbations in children with poorly controlled asthma. The study will include300 asthmatic children treated with inhaled corticosteroids, 6-16 years of age, with poor control defined by frequent symptoms, excessive beta agonist use, or frequent exacerbations. Participants will be randomly assigned to treatment with either lansoprazole or placebo for 6 months. The presence, severity, and relationship of GER to asthma symptoms will be determined with 24 hour esophageal pH monitoring, but randomization to treatment will not be influenced by the presence or severity of GER. The primary outcome measure is the proportion of participants who have exacerbations of asthma defined by diaries and interviews. Secondary outcome measures include asthma symptom and control scores, GER symptoms, lung function, and unscheduled health care contacts. Pre-defined subgroup analyses will examine the relationship between specific clinical features and the response to lansoprazole. Treatment response will also be evaluated with 3-hour post-dose plasma lansoprazole concentrations, and related to polymorphisms in CYP2C19, the cytochrome P450 pathway, and IL-1 beta, a pro-inflammatory cytokine. Tertiary studies will determine how the magnitude of GER impacts airways inflammation, as measured by the concentrations of H+ (pH) and NO in expired breath. The results of this trial sould have a major impact on the understanding and treatment of GER in children with asthma.
Condition | Intervention |
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Asthma |
Drug: lansoprazole Drug: placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Study of Acid Reflux Therapy for Children With Asthma |
Estimated Enrollment: | 300 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: lansoprazole
participants < 30 kg: 15 mg po once daily
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Placebo: Placebo Comparator |
Drug: placebo
participants < 30 kg: 15 mg po once daily participants <= 30 kg: 30 mg po once daily
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Ages Eligible for Study: | 6 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:Age:
Exclusion Criteria:
Contact: Denise Whitlock | 404-717-1733 | denise_whitlock@oz.ped.emory.edu |
United States, Georgia | |
Emory Childrens Center | Recruiting |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | William G Teague, MD | Emory University |
Responsible Party: | Emory University ( W. Gerald Teague, MD ) |
Study ID Numbers: | SARCA, 5 U01 HL080433-02 |
Study First Received: | December 27, 2007 |
Last Updated: | January 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00604851 |
Health Authority: | United States: Institutional Review Board |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate |
Asthma Lansoprazole Gastroesophageal Reflux 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 |