Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer

OBJECTIVES: Primary * Evaluate the effect, in terms of size and number reduction of computed tomography (CT) scan-detected undetermined lung nodules, in asymptomatic subjects with lung nodules at high-risk for developing lung cancer treated with inhaled budesonide vs placebo. Secondary * Compare average modification of nodule size and nodule number due to inhaled budesonide versus placebo. * Correlate the modulation of biological markers of lung cancer in serum and sputum after treatment with the modification of lung nodules sizes. * Determine treatment toxicity, side effects, and safety of inhaled budesonide. * Evaluate the role of CT scans in estimating the grade of respiratory impairment and emphysema. * Determine the effect of inhaled budesonide on respiratory function before and after treatment. OUTLINE: This is a randomized, double-blind, placebo controlled study. Participants are stratified according to gender, smoking habit (current vs former smoker), and nodule characteristics (solid vs semisolid or non-solid). Participants are randomized into 1 of 2 treatment arms. * Arm I: Subjects receive inhaled budesonide twice daily for 1 year in the absence of unacceptable toxicity. * Arm II: Subjects receive inhaled placebo twice daily for 1 year in the absence of unacceptable toxicity. Participants undergo blood and sputum collection periodically during study for biomarker and correlative studies. After completion of study therapy, subjects are followed at 1 month and continue CT scan screening. PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.