title: Randomized phase II trial of inhaled budesonide versus placebo in high-risk individuals with CT screen-detected lung nodules.
abstract: Screening CT identifies small peripheral lung nodules, some of which may be pre- or early invasive neoplasia. Secondary end point analysis of a previous chemoprevention trial in individuals with bronchial dysplasia showed reduction in size of peripheral nodules by inhaled budesonide. We performed a randomized, double-blind, placebo-controlled phase IIb trial of inhaled budesonide in current and former smokers with CT-detected lung nodules that were persistent for at least 1 year. A total of 202 individuals received inhaled budesonide, 800 μg twice daily or placebo for 1 year. The primary endpoint was the effect of treatment on target nodule size in a per person analysis after 1 year. The per person analysis showed no significant difference between the budesonide and placebo arms (response rate 2% and 1%, respectively). Although the per lesion analysis revealed a significant effect of budesonide on regression of existing target nodules (P = 0.02), the appearance of new lesions was similar in both groups and thus the significance was lost in the analysis of all lesions. The evaluation by nodule type revealed a nonsignificant trend toward regression of nonsolid and partially solid lesions after budesonide treatment. Budesonide was well tolerated, with no unexpected side effects identified. Treatment with inhaled budesonide for 1 year did not significantly affect peripheral lung nodule size. There was a trend toward regression of nonsolid and partially solid nodules after budesonide treatment. Because a subset of these nodules is more likely to represent precursors of adenocarcinoma, additional follow-up is needed.
authors.affiliation: Division of Thoracic Surgery, European Institute of Oncology, Via Ripamonti 435, I-20141 Milan, Italy. giulia.veronesi@ieo.it
authors.forename: Giulia
authors.initials: G
authors.lastname: Veronesi
authors.forename: Eva
authors.initials: E
authors.lastname: Szabo
authors.forename: Andrea
authors.initials: A
authors.lastname: Decensi
authors.forename: Aliana
authors.initials: A
authors.lastname: Guerrieri-Gonzaga
authors.forename: Massimo
authors.initials: M
authors.lastname: Bellomi
authors.forename: Davide
authors.initials: D
authors.lastname: Radice
authors.forename: Stefania
authors.initials: S
authors.lastname: Ferretti
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Pelosi
authors.forename: Matteo
authors.initials: M
authors.lastname: Lazzeroni
authors.forename: Davide
authors.initials: D
authors.lastname: Serrano
authors.forename: Scott M
authors.initials: SM
authors.lastname: Lippman
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Spaggiari
authors.forename: Angela
authors.initials: A
authors.lastname: Nardi-Pantoli
authors.forename: Sergio
authors.initials: S
authors.lastname: Harari
authors.forename: Clara
authors.initials: C
authors.lastname: Varricchio
authors.forename: Bernardo
authors.initials: B
authors.lastname: Bonanni
mesh_terms: D000280:Administration, Inhalation; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D019819:Budesonide / Q000008:administration & dosage*; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D055613:Multiple Pulmonary Nodules / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D010919:Placebos; D011379:Prognosis; D012107:Research Design; D012129:Respiratory Function Tests; D014057:Tomography, X-Ray Computed
chemical_list: D000893:Anti-Inflammatory Agents; D010919:Placebos; D019819:Budesonide