Study of Nicotine Patches in Patients With Sarcoidosis
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|ClinicalTrials.gov Identifier: NCT00701207|
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : November 8, 2021
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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 or disease||Intervention/treatment||Phase|
|Pulmonary Sarcoidosis||Drug: nicotine patch||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Modulation of Pulmonary Sarcoidosis by Nicotinic Acetylcholine Receptors|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||December 31, 2010|
|Actual Study Completion Date :||December 31, 2010|
No Intervention: 2.
control group-no intervention
No Intervention: 3
Healthy control group-blood and sputum samples
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
- To determine if nicotine treatment reduces lung inflammation. [ Time Frame: 3 months ]Normalization of immune response
- 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 ]Improvement in FVC
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- • 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).
• 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00701207
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Elliott D. Crouser, M.D.||Ohio State University|
|Responsible Party:||Elliott Crouser MD, Medical Director, Intensive Care Unit, UHE, Ohio State University|
|Other Study ID Numbers:||
S-07-006 ( Other Grant/Funding Number: American Thoracic Society )
|First Posted:||June 19, 2008 Key Record Dates|
|Last Update Posted:||November 8, 2021|
|Last Verified:||November 2021|
To determine if nicotine treatment reduces lung inflammation
Lung Diseases, Interstitial
Respiratory Tract Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action