Effects of Weight Loss in Obese Difficult-to-treat Asthmatics: a Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Asthma control questionnaire (ACQ)
研究概览
简要总结
Sixty percent of patients with difficult to control asthma seen in our outpatient clinic are obese. The impact of weight reduction in this subpopulation of asthmatics has not been studied. Our aim is to evaluate the impact of weight reduction on asthma control of these patients.
详细描述
Study design: interventional, open label, randomized
Patients selection
Thirty-three difficult to control obese asthmatic patients, aged between 18 to 65 years old will be recruited from the outpatient clinics of the Pulmonary Division of the University of Sao Paulo Hospital.
Difficult to control asthma will be defined as patients who do not achieve asthma control (according to GINA) despite best treatment regimen and checked adherence after at least three months of treatment.
Intervention: Patients will be divided in two groups: asthma treatment plus weight loss program or asthma treatment alone for 6 months without drug dose changing.
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
- None
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
- •Difficult-to-treat asthma
- •Body mass index > 30kg/m2
排除标准
- •Subjets older than 65 years
- •Current smoking
- •Past smoking history (> 10 pack-year)
- •Pregnancy
- •Contraindication for Orlistat or Sibutramine
结局指标
主要结局
Asthma control questionnaire (ACQ)
时间窗: Baseline and six months
次要结局
- Inflammatory parameters(Baseline and after 6 months)
- Pulmonary mechanics(Baseline and after 6 months)