A Randomized, Double-Blind, Placebo-Controlled, Cross-over Study to Evaluate the Effect of the Leukotriene Antagonist (Singulair©) Plus Moderate Dose Beclomethasone Compared to High Dose Beclomethasone in Obese Subjects With Moderate Persistent Asthma
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Determine the Effect of Montelukast / Moderate Dose ICS Versus High Dose ICS on Asthma Control as Measured by the Asthma Control Questionnaire.
研究概览
简要总结
Obesity is associated with increased airway inflammation and asthma severity that results in suboptimal control of asthma despite therapy with high dose inhaled corticosteroids (ICS). The investigators suggested that the addition of Singular (montelukast)[LTRA] to moderate doses of inhaled corticosteroids will improve asthma control. This cross over study will be treat subjects with moderate dose ICS/LTRA for 12 weeks and high dose ICS with placebo for 12 weeks.
详细描述
Subjects will enter the 2-week run-in period after meeting eligibility criteria at the screening visit (visit 1). During run-in subjects will have all usual asthma medications discontinued and will be placed on inhaled corticosteroids at moderate doses and leukotriene receptor antagonists will be withdrawn (LTRA wash-out). Subjects will be monitored to rule out any acute infection or symptoms consistent with an exacerbation. The run-in period will be used to assess subject compliance and understanding of study related procedures. Following the run-in, to be eligible for the randomization subjects must have an ACQ score >1.25 on the Juniper Asthma Control Questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate persistent asthma as defined daily symptoms, nocturnal awakenings >1 time/week but not daily, daily short-acting beta agonist usage
- •pre-bronchodilator Force expiratory volume (FEV1)>55% but <90%.
- •Subjects must be on controller therapy for asthma with ICS for at least one month prior to enrollment.
- •methacholine testing that causes a drop in the FEV1 of 20% (8mg/ml off ICS or 16mg/ml) on ICS within 6 months prior to entry
- •physician diagnosis of asthma for at least one year prior to study enrollment.
- •Obesity defined as BMI greater than
- •subjects must have an Asthma Control Questionnaire (ACQ) score >1.25 on the Juniper Asthma Control Questionnaire (indicating poor asthma control),
- •require daily medications for asthma and be compliant with study related medications.
排除标准
- •Subjects must not have been intubated in the last 5 years or unstable asthma symptoms resulting in significant loss or work or school
- •upper or lower respiratory tract infection within 1 month of the study
- •use of antibiotics within 4 weeks of the study
- •use of oral glucocorticoids within 4 weeks
- •use of theophylline
- •smoking history greater than 10 pack years or any cigarette use within the past two years
- •significant non-asthma pulmonary disease or other medical problems
- •Subjects planning to undergo gastric bypass surgery within 4 months of the enrollment date will be excluded since weight loss is a potential confounder of asthma control
- •Pregnant women will also be excluded
研究组 & 干预措施
leukotriene receptor antagonist (LTRA) montelukast
Montelukast (LTRA) administered with moderate dose of inhaled steroid
干预措施: Montelukast (Drug)
Sugar Pill
High dose of inhaled steroid administered with sugar pill
干预措施: Sugar pill (Other)
结局指标
主要结局
Determine the Effect of Montelukast / Moderate Dose ICS Versus High Dose ICS on Asthma Control as Measured by the Asthma Control Questionnaire.
时间窗: Baseline/randomization to week 16
次要结局
- Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)(Baseline/randomization to week 16)
- Serum Adiponectin, Leptin, Tumor Necrosis Alpha (TNF-α) and Interleukin 6 (IL6) Levels(Baseline/randomization to week 16)
- Change in Trends in Asthma Control Questionnaire (ACQ ACTQ) Scores Over Duration of the Study(Baseline/randomization to week 16)
- Asthma Exacerbation(Baseline/randomization to week 16)
- Sputum Cell Counts and Differentials(Baseline/randomization to week 16)