Lansoprazole for Children With Poorly Controlled Asthma A Randomized Controlled Trial

被引:172
作者
Holbrook, Janet T. [1 ]
Wise, Robert A. [2 ]
Gold, Benjamin D. [3 ]
Blake, Kathryn [4 ]
Brown, Ellen D. [5 ]
Castro, Mario [6 ]
Dozor, Allen J. [7 ,8 ]
Lima, John J. [4 ]
Mastronarde, John G. [9 ]
Sockrider, Marianna M. [10 ]
Teague, W. Gerald [11 ]
机构
[1] Johns Hopkins Bloomberg Sch Publ Hlth, Ctr Clin Trials, Baltimore, MD USA
[2] Johns Hopkins Univ, Sch Med, Baltimore, MD 21218 USA
[3] Childrens Ctr Digest Healthcare, Atlanta, GA USA
[4] Nemours Childrens Clin, Jacksonville, FL USA
[5] Johns Hopkins Sch Publ Hlth, Ctr Clin Trials, Baltimore, MD USA
[6] Washington Univ, Sch Med, St Louis, MO USA
[7] Westchester Cty Med Ctr, Maria Fareri Childrens Hosp, Valhalla, NY 10595 USA
[8] New York Med Coll, Valhalla, NY 10595 USA
[9] Ohio State Univ, Med Ctr, Davis Heart & Lung Res Inst, Columbus, OH 43210 USA
[10] Texas Childrens Hosp, Baylor Coll Med, Houston, TX 77030 USA
[11] Univ Virginia, Sch Med, Charlottesville, VA 22908 USA
来源
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2012年 / 307卷 / 04期
基金
美国国家卫生研究院;
关键词
GASTROESOPHAGEAL-REFLUX DISEASE; COMMUNITY-ACQUIRED PNEUMONIA; PROTON-PUMP INHIBITORS; QUALITY-OF-LIFE; RESPIRATORY SYMPTOMS; RISK; EXACERBATIONS; ASSOCIATIONS; VALIDATION; GUIDELINES;
D O I
10.1001/jama.2011.2035
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Context Asymptomatic gastroesophageal reflux (GER) is prevalent in children with asthma. Untreated GER has been postulated to be a cause of inadequate asthma control in children despite inhaled corticosteroid treatment, but it is not known whether treatment with proton pump inhibitors improves asthma control. Objective To determine whether lansoprazole is effective in reducing asthma symptoms in children without overt GER. Design, Setting, and Participants The Study of Acid Reflux in Children With Asthma, a randomized, masked, placebo-controlled, parallel clinical trial that compared lansoprazole with placebo in children with poor asthma control who were receiving inhaled corticosteroid treatment. Three hundred six participants enrolled from April 2007 to September 2010 at 19 US academic clinical centers were followed up for 24 weeks. A subgroup had an esophageal pH study before randomization. Intervention Participating children were randomly assigned to receive either lansoprazole, 15 mg/d if weighing less than 30 kg or 30 mg/d if weighing 30 kg or more (n=149), or placebo (n=157). Main Outcome Measures The primary outcome measure was change in Asthma Control Questionnaire (ACQ) score (range, 0-6; a 0.5-unit change is considered clinically meaningful). Secondary outcome measures included lung function measures, asthma-related quality of life, and episodes of poor asthma control. Results The mean age was 11 years (SD, 3 years). The mean difference in change (lansoprazole minus placebo) in the ACQ score was 0.2 units (95% CI, 0.0-0.3 units). There were no statistically significant differences in the mean difference in change for the secondary outcomes of forced expiratory volume in the first second (0.0 L; 95% CI, -0.1 to 0.1 L), asthma-related quality of life (-0.1; 95% CI, -0.3 to 0.1), or rate of episodes of poor asthma control (relative risk, 1.2; 95% CI, 0.9-1.5). Among the 115 children with esophageal pH studies, the prevalence of GER was 43%. In the subgroup with a positive pH study, no treatment effect for lansoprazole vs placebo was observed for any asthma outcome. Children treated with lansoprazole reported more respiratory infections (relative risk, 1.3 [95% CI, 1.1-1.6]). Conclusion In this trial of children with poorly controlled asthma without symptoms of GER who were using inhaled corticosteroids, the addition of lansoprazole, compared with placebo, improved neither symptoms nor lung function but was associated with increased adverse events.
引用
收藏
页码:373 / 381
页数:9
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