Study of Nicotine Patches in Patients With Sarcoidosis
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Modulation of Pulmonary Sarcoidosis by Nicotinic Acetylcholine Receptors |
- To determine if nicotine treatment reduces lung inflammation. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 64 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 2.
control group-no intervention
|
|
|
No Intervention: 3
Healthy control group-blood and sputum samples
|
|
|
Experimental: 1.
nicotine patch; transdermal patch 7mg, 14 mg., 21 mg. 3 months
|
Drug: nicotine patch
daily transdermal patch 7 mg, 14mg, 21 mg. 3 months
Other Name: Habitrol QC
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Ohio | |
| The Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| Principal Investigator: | Elliott D. Crouser, M.D. | Ohio State University |
More Information
No publications provided by Ohio State University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Elliott Crouser MD, Medical Director, Intensive Care Unit, UHE, The Ohio State University |
| ClinicalTrials.gov Identifier: | NCT00701207 History of Changes |
| Other Study ID Numbers: | 2008H0006, S-07-006 |
| Study First Received: | June 17, 2008 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Ohio State University:
|
To determine if nicotine treatment reduces lung inflammation |
Additional relevant MeSH terms:
|
Sarcoidosis Sarcoidosis, Pulmonary Lymphoproliferative Disorders Lymphatic Diseases Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013