The Effect of Montelukast on Asthma Control in Overweight/Obese Atopic Asthmatics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Asthma Control Test (ACT) Scores
研究概览
简要总结
Background: In recent years, the prevalence of both asthma and obesity has risen dramatically among children and adolescents in the United States. Given the concurrent rise in the two epidemics, there may be an underlying link. Obesity contributes to asthma severity and control, and may play a role in its underlying cause. Obesity is associated with a state of heightened inflammation that may lead to an increase asthma symptoms and severity. Obese adult patients treated with montelukast, an anti-inflammatory agent, seemed to have better asthma control than those treated with other standard asthma medications. The use of montelukast in obese children and adolescents has not been specifically studied.
Hypotheses and Specific Aims: The use of montelukast will improve asthma symptoms and objective markers of asthma to a greater degree in obese, as opposed to non-obese children and adolescents. The investigators would like to determine if the use of montelukast will improve objective asthma scores, pulmonary function, markers of inflammation and medication use to a greater degree in obese as opposed to non-obese children/adolescents.
Potential Impact: Given the growing epidemic of obesity-associated asthma in the U.S., a tailored approach focused on obese asthmatic children may help reduce the burden of this disease, health care costs and potential long-term complications as these children enter adulthood. Furthermore, this study may help clarify the underlying mechanisms that link asthma and obesity. Although this proposal is focused on one medication, it provides an example of how certain medications may have differential efficacy in the obese asthmatic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 7 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild to moderate persistent asthma based on 2007 NIH Asthma Guidelines
- •age 7-17 years old
排除标准
- •present smoking or smoking history
- •other significant pulmonary or cardiac condition
- •recent (within the past three months) use of montelukast
- •on allergen immunotherapy
- •on omalizumab
- •pregnancy
研究组 & 干预措施
Obese atopic asthmatics, montelukast
Obese/overweight (BMI 85%ile or above for children and > 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive montelukast in a double blinded fashion.
干预措施: Montelukast (Drug)
Lean atopic asthmatics, placebo
Normal weight (BMI less than 85%ile or above for children and < 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive placebo in a double blinded fashion.
干预措施: Placebo (Drug)
Lean atopic asthmatics, montelukast
Normal weight (BMI less than 85%ile or above for children and < 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive montelukast in a double blinded fashion.
干预措施: Montelukast (Drug)
Obese atopic asthmatics, Placebo
Obese/overweight (BMI 85%ile or above for children and > 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive placebo in a double blinded fashion.
干预措施: Placebo (Drug)
结局指标
主要结局
Asthma Control Test (ACT) Scores
时间窗: 24 weeks
The ACT is a validated questionaire-based tool designed to assess asthma control. Scale range for 7-11 year olds is 0-27 and for 12 years and older 5-25, with lower scores indicating poorer asthma control for all ages. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.
次要结局
- Beclomethasone Equivalents(24 weeks)
- Serum Leptin Levels(24 weeks)
- Urinary Creatinine (Cr) Levels(24 weeks)
- Spirometric Measures(24 weeks)
- Urinary Leukotriene E4 (LTE4) Levels(24 weeks)
- Urinary Creatinine (Cr) Levels/Leukotriene E4 (LTE4) Ratio(24 weeks)
- Exhaled Nitric Oxide Measurement(24 weeks)
研究者
Sherry Farzan Kashani
Attending
Northwell Health
