At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 225 enrolled
Drug / intervention
Budesonide +1 moredrug
Likely dose
Budesonide 800 microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Budesonide and Placebo for Lung Cancer. Completed, enrolled 225 participants across 1 site.
Detailed Summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of budesonide may keep lung cancer from forming in patients with lung nodules. PURPOSE: This randomized phase II trial is studying how well inhalation budesonide works in treating patients with lung nodules who are at high risk of lung cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesItaly
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2006
First PostedMay 2006
Primary CompletionSep 2008
TodayJul 2026
First PostedMay 4, 2006
Enrollment StartJan 1, 2006
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 20.2 years ago
Interventions
Budesonidedrug
Inhaled Budesonide 800 micrograms (ug) twice daily for one year.
Placeboother
Inhaled placebo twice daily for one year.