Phosphodiesterase 4 Inhibitor, Roflumilast, Improves Beta Agonist Responsiveness Compared to Placebo in Low T2 Asthma Patients.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in Beta 2 Agonist response from Baseline
研究概览
简要总结
This study evaluates the effects of roflumilast on restoring response β2 adrenoreceptor agonists in low T2, obese asthmatics. One group of participants will receive roflumilast for 3 months, while the other will receive a placebo.
详细描述
T2 low asthma is common in obese asthmatics. New evidence suggests that hyperinsulinemia and insulin resistance, both common in obesity, are associated with an increased risk of concurrent asthma.
Targeting Phosphodiesterase 4 inhibitors (PDE4) allows for examination of a mechanism potentially linking obesity and asthma as well as identification of readily available and safe options to treat hyperinsulinemic, overweight asthmatics.
It is hypothesized that obesity and hyperinsulinemia contribute to asthma by impairing β2 adrenoreceptor function and that this can be rescued the PDE4 inhibitor, roflumilast.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a physician diagnosis of asthma.
- •Require treatment with moderate to high-dose >2500mcg/day of fluticasone or equivalent, or use of oral steroids
- •Also two of the following:
- •Requirement for additional daily treatment with other controller medication
- •Daily Asthma symptoms
- •Forced Expiratory Volume / Forced Vital Capacity (FEV1/FVC) < 70% and FEV1< 80% predicted
- •≥1 urgent care visits/year
- •≥3 oral steroid bursts/year
- •Near-fatal asthma event.
- •Exhaled Nitric oxide (FeNO)<30 ppb
- •Peripheral blood eosinophil count < 300 (x10-6/ul)
- •Obesity, BMI≥30
排除标准
- •Less than 18 years of age
- •baseline FEV1 <30% predicted
- •pregnant or nursing women
- •current smokers or subject with >20 pack year history
- •any history of intolerance of, or reaction to, Roflumilast.
- •Prisoners
- •Patients with liver disease
- •Subjects with Hepatic impairment (contraindicated in moderate-to-severe liver impairment: Child-Pugh Score Class B/C) for example.
- •Patients with clinically significant psychiatric history (i.e., suicidality, etc.) and psychiatric illness
- •Patients using strong CYP 450 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin).
研究组 & 干预措施
Placebo
Placebo by mouth, once daily, for 70 days (10 weeks).
干预措施: Placebo (Drug)
Roflumilast
Roflumilast 500mcg by mouth, once daily, for 70 days (10 weeks).
干预措施: Roflumilast (Drug)
结局指标
主要结局
Change in Beta 2 Agonist response from Baseline
时间窗: 3 months
Determine whether β2 receptor responsiveness is improved in response to albuterol in Group 1 (Roflumilast) patients compared to Group 2 (Placebo) patients at the study entry.
次要结局
- Exhaled nitric oxide(3 months)
- Asthma Control Test score(3 months)