Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study

• Register: ClinicalTrials.gov
• Last refreshed on: 22 May 2023
• Main ID: NCT02265874
• Date of registration: 10/10/2014
• Prospective Registration: Yes
• Primary sponsor: Ohio State University
• Public title: Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study
• Scientific title: Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study
• Date of first enrolment: January 12, 2015
• Target sample size: 57
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02265874
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sarcoidosis

Intervention(s)

Drug: Placebo to Habitrol

Drug: Habitrol

Primary Outcome(s)

Spirometry [Time Frame: 28 weeks]

Secondary Outcome(s)

computed tomography (CT) [Time Frame: 28 weeks]

Secondary ID(s)

2014H0291

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Cleveland Clinic