Status:
COMPLETED
Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
The Cleveland Clinic
Conditions:
Sarcoidosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine if nicotine treatment is beneficial for the treatment of sarcoidosis. Sarcoidosis is a disease of unknown cause that leads to inflammation. This disease affec...
Detailed Description
Participants will be randomly divided into two groups. One group will receive a nicotine patch to use for approximately 7 months; the other group will receive placebo for nicotine patches to use for t...
Eligibility Criteria
Inclusion
- Adult male and female subjects ≥ 18 to ≤ 75 years of age will be screened for eligibility.
- Eligible adult patients will have histologically proven sarcoidosis, diagnosed at least 6 months before screening, evidence of parenchymal disease on chest radiograph, an FVC between 50% and 85% of the predicted value, and a Medical Research Council dyspnea score (47) of at least grade 1.
- Patients must have been treated with at least 10 mg/day of prednisone or equivalent or one or more immunomodulating agents (hydroxychloroquine, methotrexate, azathioprine, leflunomide) for \>3 months before screening.
- Doses of these medications must be stable for at least 1 month before study entry.
- During the study, background medication regimen and doses are to remain stable.
Exclusion
- active tobacco smoking or use of smokeless tobacco products containing nicotine,
- active cardiac or central nervous system disease,
- history of adverse reaction to nicotine or nicotine-containing products,
- patients with extensive irreversible pulmonary fibrosis (based upon lung biopsy or high resolution CT scan criterion) or inability to provide consent.
- The subject will be excluded if they have a smoking history of greater than 20 pack years, or a diagnosis of other significant respiratory disorder other, than sarcoidosis that, in the opinion of the investigator, would complicate the evaluation of response to treatment; or, history of substance abuse (drugs or alcohol) within 3 years prior to screening or other circumstances (e.g., psychiatric disease) that could interfere with the subject's adherence to protocol requirements or increase their risk of drug (nicotine) dependence.
Key Trial Info
Start Date :
October 21 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02265874
Start Date
October 21 2015
End Date
November 1 2021
Last Update
April 24 2025
Active Locations (1)
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1
Martha Morehouse Medical Pavilion 2050 Kenny Rd; Ste 2600
Columbus, Ohio, United States, 43221