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| Sponsors and Collaborators: |
Ohio State University American Thoracic Society |
|---|---|
| Information provided by: | Ohio State University |
| ClinicalTrials.gov Identifier: | NCT00701207 |
Purpose
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 |
| 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 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
2.: No Intervention
control group-no intervention
|
|
|
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
|
Drug: nicotine patch
daily transdermal patch 7 mg, 14mg, 21 mg. 3 months
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
• Active smokers,
Contacts and Locations| 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 | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Janice E. Drake, CRT 614-366-2287 janice.drake@osumc.edu | |
| Contact: Sharon Cheung, B.S. 614-366-2258 sharon.cheung@osumc.edu | |
| Principal Investigator: Elliott D. Crouser, M.D. | |
| Principal Investigator: | Elliott D. Crouser, M.D. | The Ohio State University Medical Center |
More Information
| Responsible Party: | The Ohio State University ( Elliott David Crouser, M.D./Primary Investigator ) |
| Study ID Numbers: | 2008H0006, S-07-006 |
| Study First Received: | June 17, 2008 |
| Last Updated: | January 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00701207 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
To determine if nicotine treatment reduces lung inflammation |
|
Nicotine polacrilex Neurotransmitter Agents Lung Diseases, Interstitial Nicotinic Agonists Sarcoidosis Cholinergic Agents Inflammation Lymphatic Diseases |
Respiratory Tract Diseases Nicotine Lung Diseases Acetylcholine Peripheral Nervous System Agents Lymphoproliferative Disorders Sarcoidosis, Pulmonary |
|
Neurotransmitter Agents Lung Diseases, Interstitial Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Nicotinic Agonists Physiological Effects of Drugs Sarcoidosis Cholinergic Agents Pharmacologic Actions |
Lymphatic Diseases Respiratory Tract Diseases Nicotine Autonomic Agents Lung Diseases Ganglionic Stimulants Peripheral Nervous System Agents Lymphoproliferative Disorders Sarcoidosis, Pulmonary |