Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT00321893
Status:
COMPLETED
Last Update Posted:
2016-01-25
First Post:
2006-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
OBJECTIVES:
Primary
* 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.
Secondary
* Compare average modification of nodule size and nodule number due to inhaled budesonide versus placebo.
* 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 emphysema.
* Determine the effect of inhaled budesonide on respiratory function before and after treatment.
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 unacceptable toxicity.
* Arm II: Subjects receive inhaled placebo twice daily for 1 year in the absence of unacceptable toxicity.
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.
Primary
* 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.
Secondary
* Compare average modification of nodule size and nodule number due to inhaled budesonide versus placebo.
* 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 emphysema.
* Determine the effect of inhaled budesonide on respiratory function before and after treatment.
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 unacceptable toxicity.
* Arm II: Subjects receive inhaled placebo twice daily for 1 year in the absence of unacceptable toxicity.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: