LAUSR

BACKGROUND Tobacco smoking is associated with a reduced risk of developing sarcoidosis, and we previously reported that nicotine normalizes immune responses to environmental antigens in patients with active pulmonary sarcoidosis. The effects of nicotine on pulmonary sarcoidosis progression is unknown. RESEARCH QUESTION Is nicotine treatment well-tolerated and will it improve lung function in patients with active pulmonary sarcoidosis? STUDY DESIGN AND METHODS With local IRB approval, we conducted a randomized, double-blind, controlled pilot trial of daily nicotine transdermal patch treatment (21 mg daily) or placebo patch treatment for 24 weeks. The Ohio State University Wexner Medical Center and Cleveland Clinic enrolled 50 consecutive adult subjects 18 years of age and older with active pulmonary sarcoidosis, based on symptoms (dyspnea, cough) and objective radiographic evidence of infiltrates consistent with non-fibrotic lung disease. We compared each treatment group at 26 weeks based on repeated measures of forced vital capacity (FVC), forced expiratory volume in one second (FEV1), quantitative lung texture score (LTS) based on CT texture analysis, Fatigue Assessment Score (FAS), St George Respiratory Questionnaire (SGRQ), Sarcoidosis Assessment Tool (SAT). RESULTS Nicotine treatment was associated with a clinically significant, approximately 2.1% (70 ml), improvement in FVC from baseline to 26 weeks. FVC decreased by a similar amount (2.2%) in the placebo group, with a net increase of 140 ml (95% CI: 10, 260) when comparing nicotine versus placebo treatment groups at 26 weeks. FEV1 and FAS improved marginally in the nicotine-treated group, compared to those on placebo. No improvement was observed in LTS, FAS, SGRQ or SAT. There were no reported serious adverse events or evidence of nicotine addiction. INTERPRETATION Nicotine treatment was well-tolerated in patients with active pulmonary sarcoidosis, and the preliminary findings of this pilot study suggest that it may reduce disease progression, based on FVC.