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Study of Nicotine Patches in Patients With Sarcoidosis
This study is currently recruiting participants.
Study NCT00701207   Information provided by Ohio State University
First Received: June 17, 2008   Last Updated: January 8, 2009   History of Changes

June 17, 2008
January 8, 2009
July 2008
December 2010   (final data collection date for primary outcome measure)
To determine if nicotine treatment reduces lung inflammation. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00701207 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
Study of Nicotine Patches in Patients With Sarcoidosis
Modulation of Pulmonary Sarcoidosis by Nicotinic Acetylcholine Receptors

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.

Phase IV
Interventional
Allocation:  Randomized
Endpoint Classification:  Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Open Label
Primary Purpose:  Treatment
Pulmonary Sarcoidosis
Drug: nicotine patch
daily transdermal patch 7 mg, 14mg, 21 mg. 3 months
Other Name: Habitrol QC
  • 2.: No Intervention
    control group-no intervention
  • 3: No Intervention
    Healthy control group-blood and sputum samples
  • 1.: Experimental
    nicotine patch; transdermal patch 7mg, 14 mg., 21 mg. 3 months
    Intervention: Drug: nicotine patch
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
64
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Janice E. Drake, CRT 614-366-2287 janice.drake@osumc.edu
Contact: Sharon Cheung, B.S. 614-366-2258 sharon.cheung@osumc.edu
United States
 
NCT00701207
Elliott David Crouser, M.D./Primary Investigator, The Ohio State University
2008H0006, S-07-006
Ohio State University
American Thoracic Society
Principal Investigator: Elliott D. Crouser, M.D. The Ohio State University Medical Center
Ohio State University
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP