Enhancement of Corticosteroid Efficacy in COPD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Bronchodilation
研究概览
简要总结
This is a pilot study designed to evaluate the effects of theophylline and roflumilast on circulating Histone deacetylase (HDAC) levels in subjects with COPD, and the bronchodilator effects of corticosteroids. Studies will be performed in 10 subjects with COPD nonresponsive to bronchodilators. Subjects will receive theophylline tablets for 1 week, followed by measurement of circulating HDAC and the acute effect of oral prednisone on the bronchodilator response to inhaled beta agonist. Roflumilast tablets will be added to the theophylline for a further week and the studies repeated. The study will provide preliminary data on the effects of theophylline and roflumilast on circulating HDAC levels and the effects of corticosteroids on the beta agonist bronchodilator response in COPD.
详细描述
- SUBJECTS: 10 Stable patients >45 years of age, with an established diagnosis of COPD (18), with FEV1 <60% predicted, FEV1/FVC <70% and <+15% FEV1 response to bronchodilator will be recruited. Patients of both genders will be included.
- TESTS
a) Blood: i) HDAC 2 in peripheral blood mononuclear cells: ii) Serum theophylline level b) Spirometry for measurement of FVC, FEV1 and FEV1/FVC
PROCEDURES Visit 1.
- After providing informed consent, subjects will receive a brief history and physical examination
- Blood will be drawn from a peripheral vein for HDAC2 levels (2 ml).
- Each subject will undergo baseline spirometry, which will be repeated after 3 inhalations of an albuterol inhaler.
c) Subjects will be asked to continue their regular treatment regimen, including long and short acting beta agonists and anticholinergics, as well as inhaled steroids.
d) Theophylline tablets extended-release 12 hr formulation, 300 mg orally taken every 12 hr will be dispensed, and the subject will return one week later for Visit 2. The subject will be asked to refrain from using his/her long acting beta agonists and anticholinergics for one day (24 hours) prior to Visit 2, and not to use the short acting beta agonist or take any caffeine containing drinks on the morning of visit 2. The subject will be asked to inform the P. I. should there be any adverse event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of COPD with FEV1 <60% predicted
- •FEV1/FVC <70% and <+15% FEV1 response to bronchodilator.
- •Patients of both genders will be included.
- •IRB approved written informed consent will be obtained from each subject.
排除标准
- •Recent (<1 month) exacerbation of COPD,
- •Known hypersensitivity to beta agonists, theophylline, steroids, or roflumilast.
- •Current or recent (<2 weeks) treatment with oral steroids, theophylline or other methylxanthines, or roflumlast.
- •Diagnosis or history of asthma, uncontrolled hypertension, or congestive heart failure.
- •History of Cardiac arrhythmia
- •History of seizures.
- •History of Liver disease
- •Gastrointestinal disease, including history of peptic ulcer disease.
- •Current infection or antibiotic treatment.
- •History of depression or psychiatric disease.
研究组 & 干预措施
thophylline and roflumilast
Theophylline for one week, followed by the addition of Roflumilast for a further one week.
干预措施: Theophylline (Drug)
thophylline and roflumilast
Theophylline for one week, followed by the addition of Roflumilast for a further one week.
干预措施: Roflumilast (Drug)
结局指标
主要结局
Bronchodilation
时间窗: Baseline, Week 1 and 2
Change in FEV1 L and FVC L
次要结局
- Change in HDAC2 Levels(Baseline, Week 1 and 2)
研究者
Nausherwan Burki
Professor of Medicine
UConn Health