Study of Nicotine Patches in Patients With Sarcoidosis

This study has suspended participant recruitment.
(Interim Analysis)
Sponsor:
Collaborator:
American Thoracic Society
Information provided by (Responsible Party):
Elliott Crouser MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00701207
First received: June 17, 2008
Last updated: May 2, 2013
Last verified: May 2013
  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

Resource links provided by NLM:


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 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Elliott Crouser MD
American Thoracic Society
Investigators
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
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

ClinicalTrials.gov processed this record on September 16, 2014