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Study of Nicotine Patches in Patients With Sarcoidosis

This study is not yet open for participant recruitment.
Verified by Ohio State University, June 2008

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

MedlinePlus related topics:   Sarcoidosis   

Drug Information available for:   Acetylcholine    Acetylcholine chloride    Nicotine polacrilex    Nicotine tartrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:   Modulation of Pulmonary Sarcoidosis by Nicotinic Acetylcholine Receptors

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • To determine if nicotine treatment reduces lung inflammation. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 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
3: No Intervention
Healthy control group-blood and sputum samples
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

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701207

Contacts
Contact: Janice E. Drake, CRT     614-366-2287     janice.drake@osumc.edu    
Contact: Sharon Cheung, B.S.     614-366-2258     sharon.cheung@osumc.edu    

Locations
United States, Ohio
The Ohio State University    
      Columbus, Ohio, United States, 43210

Sponsors and Collaborators
Ohio State University
American Thoracic Society

Investigators
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
First Received:   June 17, 2008
Last Updated:   June 18, 2008
ClinicalTrials.gov Identifier:   NCT00701207
Health Authority:   United States: Institutional Review Board

Keywords provided by Ohio State University:
To determine if nicotine treatment reduces lung inflammation  

Study placed in the following topic categories:
Nicotine polacrilex
Lymphatic Diseases
Lung Diseases, Interstitial
Sarcoidosis, pulmonary
Respiratory Tract Diseases
Nicotine
Lung Diseases
Acetylcholine
Sarcoidosis
Lymphoproliferative Disorders
Inflammation
Sarcoidosis, Pulmonary

Additional relevant MeSH terms:
Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Nicotinic Agonists
Physiological Effects of Drugs
Central Nervous System Stimulants
Cholinergic Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Ganglionic Stimulants
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 24, 2008




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