Randomized Phase II Trial of Budesonide Turbuhaler® 800 Micrograms/Twice Daily Versus Placebo in High-Risk Population With Undetermined Lung Nodules Detected at Screening Low Dose CT Scan
- 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.
- Compare average modification of nodule size and nodule number due to inhaled budesonide
- 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
- Determine the effect of inhaled budesonide on respiratory function before and after
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
- Arm II: Subjects receive inhaled placebo twice daily for 1 year in the absence of
Participants undergo blood and sputum collection periodically during study for biomarker and
After completion of study therapy, subjects are followed at 1 month and continue CT scan
PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Number (and Size) CT-detected Lung Nodules by Participant
Lung nodules in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Baseline to 3 Years
Giulia Veronesi, MD
European Institute of Oncology
United States: Institutional Review Board