Study of Nicotine Patches in Patients With Sarcoidosis

Early Phase 1CompletedNCT00701207

Elliott Crouser MD64 enrolled

Overview

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.

Until recently, there was no good explanation for the fact that smoking cigarettes actually reduces the risk of sarcoidosis. Research studies have shown that the nicotine, a common component of cigarette smoke, strongly suppresses the immune system and reduces the type of inflammation that is characteristic of sarcoidosis in the lungs. We propose that nicotine treatment, administered in the form of a skin patch, will reduce the severity of lung disease in patients with sarcoidosis. Sarcoidosis patients who volunteer to participate in this study will submit standardized questionnaires relating to their quality of life and the severity of their shortness of breath before and after treatment. We will also compare objective measures of lung function, radiographic parameters, and the severity of lung inflammation. We predict that nicotine treatment will reduce the severity of sarcoidosis symptoms, improve lung function, and resolve lung inflammation. If our hypothesis is proven to be correct in this relatively small group of patients, we will perform additional studies in a larger group of patients and will consider the features of sarcoidosis patients that predict a favorable response to nicotine and other nicotine-like drugs. If nicotine is ultimately found to be an effective treatment for sarcoidosis, it may replace some of the existing treatments which are frequently ineffective and have unacceptable side-effects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Sarcoidosis

Interventions

nicotine patchDRUG

daily transdermal patch 7 mg, 14mg, 21 mg. 3 months

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The Ohio State University

Columbus, Ohio, United States

Outcomes

Primary Outcomes

To determine if nicotine treatment reduces lung inflammation.

Normalization of immune response

Time frame: 3 months

Secondary Outcomes

To determine if expression of α7 nAChR on monocytes/macrophages derived from the blood/lungs correlates with the severity of pulmonary sarcoidosis.

Improvement in FVC

Time frame: 3 months

Data from ClinicalTrials.gov

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