Study of Nicotine Patches in Patients With Sarcoidosis

NCT ID: NCT00701207

Last Updated: 2021-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-12-31

Brief 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.

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.

Conditions

Pulmonary Sarcoidosis

Keywords

To determine if nicotine treatment reduces lung inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2.

control group-no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

3

Healthy control group-blood and sputum samples

Group Type: NO_INTERVENTION

No interventions assigned to this group

1.

nicotine patch; transdermal patch 7mg, 14 mg., 21 mg. 3 months

Group Type: EXPERIMENTAL

nicotine patch

Intervention Type: DRUG

daily transdermal patch 7 mg, 14mg, 21 mg. 3 months

Interventions

nicotine patch

daily transdermal patch 7 mg, 14mg, 21 mg. 3 months

Intervention Type: DRUG

Other Intervention Names

Habitrol QC

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Thoracic Society

OTHER

Sponsor Role: collaborator

Elliott Crouser MD

OTHER

Sponsor Role: lead

Responsible Party

Elliott Crouser MD

Medical Director, Intensive Care Unit, UHE

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Elliott D. Crouser, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22878868 (View on PubMed)

Other Identifiers

S-07-006

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2008H0006

Identifier Type: -

Identifier Source: org_study_id