Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-21

Study Completion Date

2021-11-01

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.

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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

Conditions

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Sarcoidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment

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

Group Type ACTIVE_COMPARATOR

Habitrol

Intervention Type DRUG

Patch used daily for 28 weeks

Control

Placebo patch

Group Type PLACEBO_COMPARATOR

Placebo to Habitrol

Intervention Type DRUG

Interventions

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Habitrol

Patch used daily for 28 weeks

Intervention Type DRUG

Placebo to Habitrol

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No