A pilot study in patients with pulmonary sarcoidosis showed nicotine treatment was well-tolerated and might have potential for reducing disease progression, though the study did not conclusively show reduced sarcoidosis progression compared with placebo. Findings of the study were recently published in the journal CHEST.
This randomized, double-blind, controlled pilot study of adult patients with active pulmonary sarcoidosis compared the effects of 26 weeks of treatment with transdermal nicotine (21 mg daily) vs placebo. Among the 50 patients recruited into the pilot study, 40 participants were followed through the end of the study at week 26. The primary outcomes were changes to pulmonary function based on measures of forced vital capacity (FVC), forced expiratory volume (FEV1), quantitative lung texture score based on CT texture analysis, Fatigue Assessment Score (FAS), St. George’s Respiratory Questionnaire (SGRQ) score, and the Sarcoidosis Assessment Tool score.
With respect to FVC, investigators found that during the study period, mean FVC increased by 2.1% (70 mL) in the nicotine group and decreased by 2.4% (70 mL) in the placebo group and, for a mean treatment effect of 140 mL (95% CI, 10-260). After adjusting for baseline FVC (which was higher in the nicotine treatment group), nicotine treatment was associated with a modest but statistically significant improvement in FVC.
With respect to other outcomes, FEV1 and FAS improved slightly in the nicotine-treated group compared with the placebo group. No improvement was observed in scores with respect to lung texture, FAS, St. George’s Respiratory Questionnaire, or the Sarcoidosis Assessment Tool. Overall, nicotine treatment was well tolerated, was not addictive, and resulted in no serious adverse events.
The study authors concluded that “the preliminary findings of this pilot study suggest that “nicotine treatment” may reduce disease progression, based on FVC.” They added that “Additional studies are required to determine if nicotine is a viable alternative to prednisone, the current recommended first-line therapy, for the treatment of pulmonary sarcoidosis.”
Crouser ED, Smith RM, Culver DA, et al. A pilot randomized trial of transdermal nicotine for pulmonary sarcoidosis. CHEST. 2021;160(4):1340-1349. doi:10.1016/j.chest.2021.05.031