Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

The Ohio State University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Sarcoidosis

Treatments: Drug: Placebo to Habitrol; Drug: Habitrol

Study type: Interventional

Funder types: Other

Identifiers

NCT02265874

2014H0291

Details and patient eligibility

About

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.

Full 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 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

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Treatment

Active Comparator group

Description:

Habitrol Nicotine patch - 7,14,21 mg patches Qd

Treatment:

Drug: Habitrol

Control

Placebo Comparator group

Description:

Placebo patch

Treatment:

Drug: Placebo to Habitrol