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Sponsors and Collaborators: |
Ohio State University American Thoracic Society |
Information provided by: | Ohio State University |
ClinicalTrials.gov Identifier: | NCT00701207 |
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.
Condition | Intervention | Phase |
Pulmonary Sarcoidosis |
Drug: nicotine patch |
Phase IV |
MedlinePlus related topics: | Sarcoidosis |
Drug Information available for: | Acetylcholine Acetylcholine chloride Nicotine polacrilex Nicotine tartrate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Modulation of Pulmonary Sarcoidosis by Nicotinic Acetylcholine Receptors |
Estimated Enrollment: | 64 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
2.: No Intervention
control group-no intervention
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3: No Intervention
Healthy control group-blood and sputum samples
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1.: Experimental
nicotine patch; transdermal patch 7mg, 14 mg., 21 mg. 3 months
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Drug: nicotine patch
daily transdermal patch 7 mg, 14mg, 21 mg. 3 months
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
• Active smokers,
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, Ohio | |||||
The Ohio State University | |||||
Columbus, Ohio, United States, 43210 |
Ohio State University |
American Thoracic Society |
Principal Investigator: | Elliott D. Crouser, M.D. | The Ohio State University Medical Center |
Responsible Party: | The Ohio State University ( Elliott David Crouser, M.D./Primary Investigator ) |
Study ID Numbers: | 2008H0006, S-07-006 |
First Received: | June 17, 2008 |
Last Updated: | June 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00701207 |
Health Authority: | United States: Institutional Review Board |
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