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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
Sponsor:
Collaborator:
American Thoracic Society
Information provided by (Responsible Party):
Elliott Crouser MD, Ohio State University

Study Description
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Brief Summary:

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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. To determine if nicotine treatment reduces lung inflammation. [ Time Frame: 3 months ]
    Normalization of immune response


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

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


Locations
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United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Elliott Crouser MD
American Thoracic Society
Investigators
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Principal Investigator: Elliott D. Crouser, M.D. Ohio State University
More Information
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Publications:

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Responsible Party: Elliott Crouser MD, Medical Director, Intensive Care Unit, UHE, Ohio State University
ClinicalTrials.gov Identifier: NCT00701207    
Other Study ID Numbers: 2008H0006
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
Keywords provided by Elliott Crouser MD, Ohio State University:
To determine if nicotine treatment reduces lung inflammation
Additional relevant MeSH terms:
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Sarcoidosis, Pulmonary
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Nicotine
Ganglionic Stimulants
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action