Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reduction in number of episodes of acute exacerbation
研究概览
简要总结
Pulmonary sarcoidosis patients with fibrosis often develop recurrent episodes of bronchitis. These can lead to worsening of disease for both the short and long term.
Roflumilast has been shown to reduce the number of acute bronchitis episodes in patients with COPD.
Drugs similar to Roflumilast have been shown to help sarcoidosis. The current study is to determine if Roflumilast will reduce number of episodes of bronchitis and help fibrotic sarcoidosis.
详细描述
This will be a multicenter, double blind, placebo controlled study. Patients would be randomized 1:1 to receive either roflumilast 500 mcg per day or placebo added to their current treatment regimen for twelve months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with sarcoidosis as defined by the American Thoracic Society criteria
- •Patients with an FEV1/FVC ratio of less than 80%
- •Patients with fibrosis on chest x-ray and/or high resolution CT scan.
- •Patients have had at least two exacerbations of their sarcoidosis in the prior year. An exacerbation is defined as an acute event requiring increase of prednisone with or without use of antibiotics.
- •Patients must be on a stable dose of corticosteroids and other agents for their sarcoidosis at least 4 weeks prior to first visit.
- •For patients on prednisone alone, the dose has to be the equivalent of 5 mg prednisone a day. For those on other immunosuppressants, they can be on any dose of prednisone.
- •Patients must be between ages of 18 and 70 years of age.
- •Willing to take prednisone at increased dosage for exacerbations of their sarcoidosis.
- •Patients must be able to provide written informed consent to participate in the study.
排除标准
- •Patients with known hypersensitivity to theophylline or pentoxifylline will not be eligible. Patients with dose dependent nausea from these drugs may still participate in the trial.
- •Patients will not be able to take theophylline or pentoxifylline during the time of the study. They will be allowed to take drugs for sarcoidosis including prednisone, methotrexate, azathioprine, leflunomide, hydroxychloroquine, thalidomide, infliximab, adalimumab, and rituximab.
- •Patients with serum creatinine of greater than 3 mg/dL
- •Patients with moderate or severe liver disease as defined Child Pugh class 3 or
- •Patients with unstable cardiac disease
- •Patients with non cutaneous malignancy treated in the past two years.
- •Patients unable to complete the questionnaires and six minute walks detailed in the study.Women of child bearing potential unable to use adequate birth control as determined by the investigator.
研究组 & 干预措施
Roflumilast
Roflumilast
干预措施: Roflumilast (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction in number of episodes of acute exacerbation
时间窗: one year
Collect number of episodes of exacerbtion in one year
次要结局
- Change in FVC(one year)
- Changes in quality of life(One year)
研究者
Robert P Baughman
Professor of Medicine
University of Cincinnati