Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Forced Vital Capacity (FVC)
研究概览
简要总结
The purpose of this study is to determine if nicotine treatment is beneficial for the treatment of sarcoidosis. Sarcoidosis is a disease of unknown cause that leads to inflammation. This disease affects your body's organs.
详细描述
Participants will be randomly divided into two groups. One group will receive a nicotine patch to use for approximately 7 months; the other group will receive placebo for nicotine patches to use for the same time period.
Both groups will be contacted weekly by phone for the first 3 weeks then monthly for the duration of the study to monitor for any side effects.
The following information and samples will be collected:
Questionnaires Medical History Spirometry CT Scans Physical Exam Blood Samples for nicotine and nicotine metabolites
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female subjects ≥ 18 to ≤ 75 years of age will be screened for eligibility.
- •Eligible adult patients will have histologically proven sarcoidosis, diagnosed at least 6 months before screening, evidence of parenchymal disease on chest radiograph, an FVC between 50% and 85% of the predicted value, and a Medical Research Council dyspnea score (47) of at least grade
- •Patients must have been treated with at least 10 mg/day of prednisone or equivalent or one or more immunomodulating agents (hydroxychloroquine, methotrexate, azathioprine, leflunomide) for >3 months before screening.
- •Doses of these medications must be stable for at least 1 month before study entry.
- •During the study, background medication regimen and doses are to remain stable.
排除标准
- •active tobacco smoking or use of smokeless tobacco products containing nicotine,
- •active cardiac or central nervous system disease,
- •history of adverse reaction to nicotine or nicotine-containing products,
- •patients with extensive irreversible pulmonary fibrosis (based upon lung biopsy or high resolution CT scan criterion) or inability to provide consent.
- •The subject will be excluded if they have a smoking history of greater than 20 pack years, or a diagnosis of other significant respiratory disorder other, than sarcoidosis that, in the opinion of the investigator, would complicate the evaluation of response to treatment; or, history of substance abuse (drugs or alcohol) within 3 years prior to screening or other circumstances (e.g., psychiatric disease) that could interfere with the subject's adherence to protocol requirements or increase their risk of drug (nicotine) dependence.
研究组 & 干预措施
Control
Placebo patch
干预措施: Placebo to Habitrol (Drug)
Treatment
Habitrol Nicotine patch - 7,14,21 mg patches Qd
干预措施: Habitrol (Drug)
结局指标
主要结局
Forced Vital Capacity (FVC)
时间窗: 28 weeks
changes in forced vital capacity (FVC) measured by pulmonary function testing (breathing tests) measured in liters
次要结局
- Changes Detected by Computed Tomography (CT) of Lungs(28 weeks)
研究者
Elliott Crouser
Principal Investigator
Ohio State University