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

NCT00321893 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2016-01-25

Study results available
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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.

Conditions

Interventions

DRUG

Budesonide

Inhaled Budesonide 800 micrograms (ug) twice daily for one year.

OTHER

Placebo

Inhaled placebo twice daily for one year.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Giulia Veronesi, MD · European Institute of Oncology

  • Scott M. Lippman, MD, FACP · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00321893 on ClinicalTrials.gov