Study of Acid Reflux Therapy for Children with Asthma

儿童哮喘胃酸反流治疗研究

• 批准号: 7878802
• 负责人: WILLIAM GERALD TEAGUE
• 金额: $ 29.61万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-20 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7878802
• 关键词: 16 year old; Acids; Adrenal Cortex Hormones; Age; Agonist; Asthma; Breathing; Bronchial Spasm; CYP2C19 gene; Child; Clinical; Clinical Trials; Clinical Trials Cooperative Group; Cytochrome P450; Dose; Effectiveness; Esophageal; Frequencies; Gastric Acid; Gastroesophageal reflux disease; Genetic Polymorphism; Goals; Health Services Accessibility; Healthcare; Hour; Individual; Inflammatory; Interleukin-1 beta; Interview; Lansoprazole; Masks; Measures; Medical; Metabolism; Monitor; Multi-Institutional Clinical Trial; Nitric Oxide; Nucleotides; Outcome Measure; Participant; Pathway interactions; Patients; Pharmaceutical Preparations; Placebos; Plasma; Production; Proton Pump Inhibitors; Randomized; Randomized Clinical Trials; Reflux; Research Personnel; Respiratory physiology; Safety; Severities; Site; Subgroup; Symptoms; Teenagers; Testing; airway inflammation; cytokine; diaries; health related quality of life; improved; methacholine; primary outcome; programs; prospective; response; secondary outcome; treatment response

DESCRIPTION (provided by applicant): Gastroesophageal reflux (GER) is frequent in children with asthma, can induce bronchospasm, and increase airways reactivity. Children with asthma are often treated for GER with drugs to suppress gastric acid production. However, this treatment is expensive, and with unproven benefit. The primary objective in this proposal 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 include 300 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 six 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 presences 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 should have a major impact on the understanding and treatment of GER in children with asthma.

描述（由申请人提供）：

项目成果

ALOX5 polymorphism associates with increased leukotriene production and reduced lung function and asthma control in children with poorly controlled asthma.

• DOI: 10.1111/cea.12076
• 发表时间: 2013-05
• 期刊: Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology
• 作者: Mougey E;Lang JE;Allayee H;Teague WG;Dozor AJ;Wise RA;Lima JJ
• 通讯作者: Lima JJ