Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321893
Status:
COMPLETED
Last Update Posted:
2016-01-25
First Post:
2006-05-02
Brief Title:
Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase II Trial of Budesonide Turbuhaler 800 MicrogramsTwice 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MDA-05-5-01 | None | None | None |
| MDA-S262505 | None | None | None |
| MDA-2005-0953 | OTHER | None | None |
| EUDRACT-2005-004614-32 | None | None | None |
| CDR0000470861 | None | None | None |
| NCI-2012-02113 | REGISTRY | NCIs Clinical Trials Reporting Program CTRP | None |