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Study of Nicotine Patches in Patients With Sarcoidosis

This study is not yet open for participant recruitment.
Study NCT00701207.   Last updated on June 18, 2008.   Information provided by Ohio State University

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Descriptive Information Fields
Brief Title  Study of Nicotine Patches in Patients With Sarcoidosis
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 Description

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 Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary Outcome Measure  To determine if nicotine treatment reduces lung inflammation. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measure  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 ] [ Designated as safety issue: No ]
Condition  Pulmonary Sarcoidosis
Intervention  Drug: nicotine patch
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Not yet recruiting
Enrollment  64
Start Date  July 2008
Completion Date December 2009
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Janice E. Drake, CRT     614-366-2287     janice.drake@osumc.edu    
Contact: Sharon Cheung, B.S.     614-366-2258     sharon.cheung@osumc.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00701207
Organization ID 2008H0006
Secondary IDs †† S-07-006
Study Sponsor  Ohio State University
Collaborators †† American Thoracic Society
Investigators 
Principal Investigator:     Elliott D. Crouser, M.D.     The Ohio State University Medical Center    
Information Provided By Ohio State University
Verification Date June 2008
First Received Date  June 17, 2008
Last Updated Date June 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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