Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

2014H0291

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.

2015-01-12

2021-11-01

2021-11-01

Completed

Early phase I

57

Inclusion Criteria: * 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 1. * 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. Exclusion Criteria: * 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.

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2023-05-12