Study of Nicotine Patches in Patients With Sarcoidosis - Full Text View

Sponsor:	Ohio State University
Collaborator:	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

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:

MedlinePlus related topics: Sarcoidosis

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

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 2012
Estimated Primary Completion Date:	December 2011 (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

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

Ohio State University

American Thoracic Society

Investigators

Principal Investigator:

Elliott D. Crouser, M.D.

The Ohio State University Medical Center

More Information

No publications provided

Responsible Party:	Elliott David Crouser, M.D./Primary Investigator, 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:	February 8, 2011
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 February 09, 2012