Division of Pulmonary and Sleep Medicine, Nemours Children's Hospital, Orlando, FL, USA.
Contemp Clin Trials. 2013 Mar;34(2):326-35. doi: 10.1016/j.cct.2012.12.009. Epub 2013 Jan 6.
Uncontrolled asthma is a major cause of hospitalizations and emergency room visits. Factors including obesity, African ancestry and childhood are associated with increased asthma severity. Considering the high morbidity caused by asthma, relatively few classes of drugs exist to control this common disease. Therefore, new therapeutic strategies may be needed to reduce asthma's impact on public health. Data suggest that a high fat diet that is deficient in omega-3 fatty acids could promote both obesity and excessive inflammation, resulting in greater asthma severity. Small trials with supplemental omega-3 fatty acids have been conducted with encouraging but inconsistent results. The variability in response seen in past trials may be due to the past subjects' genetics (specifically ALOX5 rs59439148) or their particular asthma phenotypes. Therefore, the "Nutrigenetic response to Omega-3 Fatty acids in Obese Asthmatics (NOOA)" trial is currently underway and was designed as a randomized, double-blind, placebo controlled intervention study to determine if supplemental omega-3 fatty acids improves symptoms among obese adolescents and young adults with uncontrolled asthma. Here we report the design and rationale for the NOOA trial. Participants were given either 3.18 g daily of eicosapentaenoic acid and 822 mg daily docosahexaenoic acid, or matched control soy oil, for 24 weeks. Change in the asthma control questionnaire score was the primary outcome. Secondary outcomes included spirometry, impulse oscillometry, exacerbation rate, airway biomarkers, systemic inflammation, leukotriene biosynthesis and T-lymphocyte function. NOOA may lead to a new therapeutic treatment strategy and greater understanding of the mechanistic role of diet in the pathogenesis of asthma.
未控制的哮喘是住院和急诊就诊的主要原因。肥胖、非裔血统和儿童时期等因素与哮喘严重程度增加有关。考虑到哮喘引起的高发病率,目前仅有相对较少类别的药物可用于控制这种常见疾病。因此,可能需要新的治疗策略来减轻哮喘对公共健康的影响。有数据表明,缺乏ω-3 脂肪酸的高脂肪饮食可能会促进肥胖和过度炎症,从而导致哮喘加重。已经进行了一些补充ω-3 脂肪酸的小型试验,但结果喜忧参半。过去试验中观察到的反应变异性可能是由于过去研究对象的遗传因素(特别是 ALOX5 rs59439148)或其特定的哮喘表型所致。因此,目前正在进行“肥胖哮喘患者ω-3 脂肪酸的营养遗传反应(NOOA)”试验,该试验设计为随机、双盲、安慰剂对照干预研究,以确定补充 ω-3 脂肪酸是否可改善未控制的肥胖青少年和年轻成年人的哮喘症状。在这里,我们报告了 NOOA 试验的设计和原理。参与者每天服用 3.18 克二十碳五烯酸和 822 毫克二十二碳六烯酸,或服用等量的匹配对照大豆油,持续 24 周。哮喘控制问卷评分的变化是主要结局。次要结局包括肺功能检查、脉冲振荡检查、加重率、气道生物标志物、全身炎症、白三烯生物合成和 T 淋巴细胞功能。NOOA 可能会产生新的治疗策略,并更深入地了解饮食在哮喘发病机制中的机制作用。