Status:
COMPLETED
Study of Nicotine Patches in Patients With Sarcoidosis
Lead Sponsor:
Elliott Crouser MD
Collaborating Sponsors:
American Thoracic Society
Conditions:
Pulmonary Sarcoidosis
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 ...
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 cigare...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2010
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00701207
Start Date
July 1 2008
End Date
December 31 2010
Last Update
November 8 2021
Active Locations (1)
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1
The Ohio State University
Columbus, Ohio, United States, 43210