Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

Study Overview
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Brief Summary
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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 affects your body's organs.

Detailed Description
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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 the same time period. Both groups will be contacted weekly by phone for the first 3 weeks then monthly for the duration of the study to monitor for any side effects. The following information and samples will be collected: Questionnaires Medical History Spirometry CT Scans Physical Exam Blood Samples for nicotine and nicotine metabolites

Official Title
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Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

Conditions
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Sarcoidosis

Intervention / Treatment
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* Drug: Habitrol
* Drug: Placebo to Habitrol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>Habitrol Nicotine patch - 7,14,21 mg patches Qd | Drug: Habitrol<br>* Patch used daily for 28 weeks<br>|
| Placebo Comparator: Control<br>Placebo patch | Drug: Placebo to Habitrol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry | changes in forced vital capacity (FVC) | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| computed tomography (CT) | image analysis to detect common manifestations and its forced correlations with FVC | 28 weeks |