Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

• Status: Completed
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University
• Collaborator: The Cleveland Clinic
• Treatments: Nicotine

Criteria

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.