Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

Phase 1

Completed

Conditions: Sarcoidosis

Interventions: Drug: Placebo to Habitrol
Drug: Habitrol

Registration Number: NCT02265874

Lead Sponsor: Ohio State University

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 affects your body's organs.

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 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	Placebo to Habitrol	Placebo patch
Treatment	Habitrol	Habitrol Nicotine patch - 7,14,21 mg patches Qd

Primary Outcome Measures

Name	Time	Method
Forced Vital Capacity (FVC)	28 weeks	changes in forced vital capacity (FVC) measured by pulmonary function testing (breathing tests) measured in liters

Secondary Outcome Measures

Name	Time	Method
Changes Detected by Computed Tomography (CT) of Lungs	28 weeks	CT lung scans are analyzed by a computer program: Briefly, lung architecture, manifest as pixelated Houndsfield units, is assessed for regional mismatches (texture), wherein linear conformation of pixels are removed (equating with airways, blood or lymphatic vessels) and the mismatched pixels are quantified (i.e., Lung Texture Score; LTS) and are reflective of lung anatomy, including lung nodules, interstitial fibrosis or alveolar ground glass (i.e., pulmonary sarcoidosis manifestations). LTS is represented by arbitrary units, and are reported to range from 25 - 70; 25-40 being within the normal range (i.e., normal lung anatomy; and values in the 40 - 70 range are associated lung parenchymal disease (PMID: 22628482).