Clinical trial NCT02265874: Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study
Official title: Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sarcoidosis
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
First posted: 2014-10-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: 28 weeks
Secondary outcomes:
measure: Changes Detected by Computed Tomography (CT) of Lungs
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Martha Morehouse Medical Pavilion 2050 Kenny Rd; Ste 2600
state: Ohio
Study officials:
References:
citation: Crouser ED, Smith RM, Culver DA, Julian MW, Martin K, Baran J, Diaz C, Erdal BS, Hade EM. A Pilot Randomized Trial of Transdermal Nicotine for Pulmonary Sarcoidosis. Chest. 2021 Oct;160(4):1340-1349. doi: 10.1016/j.chest.2021.05.031. Epub 2021 May 23.
citation: Hade EM, Smith RM, Culver DA, Crouser ED. Design, rationale, and baseline characteristics of a pilot randomized clinical trial of nicotine treatment for pulmonary sarcoidosis. Contemp Clin Trials Commun. 2020 Oct 7;20:100669. doi: 10.1016/j.conctc.2020.100669. eCollection 2020 Dec.