CT detected indeterminate pulmonary nodules in a chemoprevention trial of fluticasone

Introduction: In animal models of lung carcinogenesis, inhaled corticosteroids appear to reduce the number of new lung tumors. In a trial of budesonide in smokers with bronchial dysplasia, the proportion of indeterminate CT detected pulmonary nodules that resolved was larger in the treatment group. We performed a secondary analysis of CT data of subjects at risk of lung cancer enrolled in a chemoprevention trial of fluticasone. Methods: Subjects with bronchial squamous metaplasia or dysplasia had a baseline chest CT scan. They were randomized to fluticasone or a placebo. After 6 months a repeat CT was performed and the change in number and size of nodules was evaluated. Results: Two hundred and one subjects were screened. Of the 108 volunteers included in the study, 74 were male, mean age was 53 years and mean number of pack years 48. Baseline: 35 subjects had 91 nodules in total, 62% <4 mm. In the fluticasone arm more subjects had a decrease and fewer had an increase in number of nodules, however this trend did not reach statistical significance. Conclusion: In this preliminary study there was a tendency of nodules to resolve, however, studies with CT detected nodules as inclusion criterion are needed.