Study of Nicotine Patches in Patients With Sarcoidosis

Pulmonary Sarcoidosis Clinical Trial

Official title:

Modulation of Pulmonary Sarcoidosis by Nicotinic Acetylcholine Receptors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701207
• Other study ID #: 2008H0006
• Secondary ID: S-07-006
• Status: Completed
• Phase: Early Phase 1
• Start date: July 2008
• Est. completion date: December 31, 2010

Study information

• Verified date: November 2021
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 31, 2010
• Est. primary completion date: December 31, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Sarcoidosis
• Sarcoidosis
• Sarcoidosis, Pulmonary

Intervention

Drug:
• nicotine patch
daily transdermal patch 7 mg, 14mg, 21 mg. 3 months

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Elliott Crouser MD	American Thoracic Society

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if nicotine treatment reduces lung inflammation.	Normalization of immune response	3 months
Secondary	To determine if expression of a7 nAChR on monocytes/macrophages derived from the blood/lungs correlates with the severity of pulmonary sarcoidosis.	Improvement in FVC	3 months