Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

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

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.