Study of Nicotine Patches in Patients With Sarcoidosis

• Register: ClinicalTrials.gov
• Last refreshed on: 15 November 2021
• Main ID: NCT00701207
• Date of registration: 17/06/2008
• Prospective Registration: Yes
• Primary sponsor: Elliott Crouser MD
• Public title: Study of Nicotine Patches in Patients With Sarcoidosis
• Scientific title: Modulation of Pulmonary Sarcoidosis by Nicotinic Acetylcholine Receptors
• Date of first enrolment: July 2008
• Target sample size: 64
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00701207
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Early Phase 1

Countries of recruitment

United States

Contacts

• Name: Elliott D. Crouser, M.D.
• Affiliation: Ohio State University

Key inclusion & exclusion criteria

Inclusion Criteria:

- • Symptomatic (active) granulomatous lung disease (radiographic stage II or III
disease) at least 6 months after the diagnosis. This selects patients that have the
chronically active variant of sarcoidosis and will likely require long-term treatment
(33).

Exclusion Criteria:

- • Active smokers,

- Previous splenectomy,

- Those requiring high-dose immunosuppression [i.e., = 0.2 mg/kg/day prednisone (or
equivalent) or > 10 mg/week methotrexate or requires second line cytolytic agents
(e.g., cyclophosphamide, azathioprine) or anti-TNF treatments (e.g., thalidomide,
anti-TNF antibodies, etc.)] to control disease activity.

- We will also exclude patients at high risk of complications relating to the use
of nicotine. This will include patients with a known intolerance of nicotine or
those with active cardiac or central nervous system disease who are at higher
risk of cardiac arrhythmias or seizures.

- We will also exclude patients with extensive pulmonary fibrosis based upon lung
biopsy or high resolution CT scan criterion



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Sarcoidosis

Intervention(s)

Drug: nicotine patch

Primary Outcome(s)

To determine if nicotine treatment reduces lung inflammation. [Time Frame: 3 months]

Secondary Outcome(s)

To determine if expression of a7 nAChR on monocytes/macrophages derived from the blood/lungs correlates with the severity of pulmonary sarcoidosis. [Time Frame: 3 months]

Secondary ID(s)

2008H0006

S-07-006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

American Thoracic Society