Document Detail


Randomized phase II trial of inhaled budesonide versus placebo in high-risk individuals with CT screen-detected lung nodules.
MedLine Citation:
PMID:  21163939     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
Giulia Veronesi; Eva Szabo; Andrea Decensi; Aliana Guerrieri-Gonzaga; Massimo Bellomi; Davide Radice; Stefania Ferretti; Giuseppe Pelosi; Matteo Lazzeroni; Davide Serrano; Scott M Lippman; Lorenzo Spaggiari; Angela Nardi-Pantoli; Sergio Harari; Clara Varricchio; Bernardo Bonanni
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural     Date:  2010-12-16
Journal Detail:
Title:  Cancer prevention research (Philadelphia, Pa.)     Volume:  4     ISSN:  1940-6215     ISO Abbreviation:  Cancer Prev Res (Phila)     Publication Date:  2011 Jan 
Date Detail:
Created Date:  2011-01-05     Completed Date:  2011-04-28     Revised Date:  2013-07-03    
Medline Journal Info:
Nlm Unique ID:  101479409     Medline TA:  Cancer Prev Res (Phila)     Country:  United States    
Other Details:
Languages:  eng     Pagination:  34-42     Citation Subset:  IM    
Copyright Information:
©2010 AACR.
Affiliation:
Division of Thoracic Surgery, European Institute of Oncology, Via Ripamonti 435, I-20141 Milan, Italy. giulia.veronesi@ieo.it
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00321893
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MeSH Terms
Descriptor/Qualifier:
Administration, Inhalation
Aged
Anti-Inflammatory Agents / administration & dosage*
Budesonide / administration & dosage*
Double-Blind Method
Endpoint Determination
Female
Humans
Lung Neoplasms / drug therapy*,  radiography*
Male
Middle Aged
Multiple Pulmonary Nodules / drug therapy*,  radiography*
Placebos
Prognosis
Research Design
Respiratory Function Tests
Tomography, X-Ray Computed
Grant Support
ID/Acronym/Agency:
N01 CN035159/CN/NCI NIH HHS; N01-CN-35159/CN/NCI NIH HHS
Chemical
Reg. No./Substance:
0/Anti-Inflammatory Agents; 0/Placebos; 51333-22-3/Budesonide
Comments/Corrections

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