Study of Nicotine Patches in Patients With Sarcoidosis

• Status: Completed
• Trial end date: 2010-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare peoples with disease (sarcoidosis) to those without disease. We want to see if people with sarcoidosis have a different immune response to those people without disease.

The goal of this study is to see if the nicotine patch is an anti-inflammatory treatment for sarcoidosis.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Elliott Crouser MD
• Collaborator: American Thoracic Society
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• • Symptomatic (active) granulomatous lung disease (radiographic stage II or III disease) at least 6 months after the diagnosis. This selects patients that have the chronically active variant of sarcoidosis and will likely require long-term treatment (33).

Exclusion Criteria:

• • Active smokers,

• Previous splenectomy,

• Those requiring high-dose immunosuppression [i.e., ≥ 0.2 mg/kg/day prednisone (or equivalent) or > 10 mg/week methotrexate or requires second line cytolytic agents (e.g., cyclophosphamide, azathioprine) or anti-TNF treatments (e.g., thalidomide, anti-TNF antibodies, etc.)] to control disease activity.

• We will also exclude patients at high risk of complications relating to the use of nicotine. This will include patients with a known intolerance of nicotine or those with active cardiac or central nervous system disease who are at higher risk of cardiac arrhythmias or seizures.

• We will also exclude patients with extensive pulmonary fibrosis based upon lung biopsy or high resolution CT scan criterion