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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00321893 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: Budesonide Other: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 202 |
| Study Start Date: | April 2006 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Budesonide: Experimental
Inhaled Budesonide 2x daily for 1 year
|
Drug: Budesonide
Inhaled Budesonide 800 micrograms twice daily for one year.
|
|
Arm II: Placebo: Placebo Comparator
Inhaled placebo 2x daily for 1 year
|
Other: Placebo
Inhaled placebo twice daily for one year.
|
OBJECTIVES:
Primary
Secondary
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.
Participants undergo blood and sputum collection periodically during study for biomarker and correlative studies.
After completion of study therapy, subjects are followed at 1 month and continue CT scan screening.
PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Italy | |
| European Institute of Oncology | |
| Milan, Italy, 20141 | |
| Study Chair: | Giulia Veronesi, MD | European Institute of Oncology |
| Study Chair: | Scott M. Lippman, MD, FACP | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | UT MD Anderson Cancer Center ( Scott M. Lippman, MD, BS / Professor ) |
| Study ID Numbers: | 2005-0953, MDA-05-5-01, MDA-S262/505, MDA-2005-0953, EUDRACT-2005-004614-32, CDR0000470861 |
| Study First Received: | May 2, 2006 |
| Last Updated: | January 25, 2010 |
| ClinicalTrials.gov Identifier: | NCT00321893 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Small cell lung cancer Non-small cell lung cancer Budesonide Entocort EC |
Pulmicort Respules Rhinocort aqua Aerosol budesonide treatment Smoking |
|
Anti-Inflammatory Agents Thoracic Neoplasms Respiratory System Agents Respiratory Tract Neoplasms Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Hormones Glucocorticoids |
Pharmacologic Actions Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Autonomic Agents Therapeutic Uses Lung Diseases Peripheral Nervous System Agents Bronchodilator Agents |