Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

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.