Study of Nicotine Patches in Patients With Sarcoidosis

Modulation of Pulmonary Sarcoidosis by Nicotinic Acetylcholine Receptors

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Sarcoidosis
• Intervention / Treatment: Drug: nicotine patch

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Early Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: Habitrol QC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine if nicotine treatment reduces lung inflammation.	Normalization of immune response	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine if expression of α7 nAChR on monocytes/macrophages derived from the blood/lungs correlates with the severity of pulmonary sarcoidosis.	Improvement in FVC	3 months

Collaborators and Investigators

• Sponsor: Elliott Crouser MD
• Collaborators: American Thoracic Society
• Investigators: Principal Investigator: Elliott D. Crouser, M.D., Ohio State University

Publications and helpful links

General Publications

• Julian MW, Shao G, Schlesinger LS, Huang Q, Cosmar DG, Bhatt NY, Culver DA, Baughman RP, Wood KL, Crouser ED. Nicotine treatment improves Toll-like receptor 2 and Toll-like receptor 9 responsiveness in active pulmonary sarcoidosis. Chest. 2013 Feb 1;143(2):461-470. doi: 10.1378/chest.12-0383.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): December 31, 2010
• Study Completion (Actual): December 31, 2010

Study Registration Dates

• First Submitted: June 17, 2008
• First Submitted That Met QC Criteria: June 18, 2008
• First Posted (Estimate): June 19, 2008

Study Record Updates

• Last Update Posted (Actual): November 8, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: To determine if nicotine treatment reduces lung inflammation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Lung Diseases; Lung Diseases, Interstitial; Sarcoidosis, Pulmonary; Sarcoidosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2008H0006; S-07-006 (Other Grant/Funding Number: American Thoracic Society)