Clinical Trial: Study of Nicotine Patches in Patients With Sarcoidosis
Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional
Official Title: Modulation of Pulmonary Sarcoidosis by Nicotinic Acetylcholine Receptors
Brief 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.
Detailed Summary: 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.
Sponsor: Elliott Crouser MD
Current Primary Outcome: To determine if nicotine treatment reduces lung inflammation. [ Time Frame: 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: To determine if expression of α7 nAChR on monocytes/macrophages derived from the blood/lungs correlates with the severity of pulmonary sarcoidosis. [ Time Frame: 3 months ]
Original Secondary Outcome: Same as current
Information By: Ohio State University
Dates:
Date Received: June 17, 2008
Date Started: July 2008
Date Completion: December 2013
Last Updated: May 2, 2013
Last Verified: May 2013
