Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005880
Status:
COMPLETED
Last Update Posted:
2008-07-24
First Post:
2000-06-02
Brief Title:
Budesonide in Treating Former and Current Smokers With Bronchial Dysplasia
Sponsor:
British Columbia Cancer Agency
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Inhaled Budesonide Pulmicort Turbuhaler in Persons With Dysplasia of the Bronchial Epithelium
Status:
COMPLETED
Status Verified Date:
2007-07
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 therapy is the use of certain drugs to try to prevent the development or recurrence of cancer The use of budesonide may be an effective way to prevent bronchial dysplasia
PURPOSE Randomized double-blinded phase II trial to determine the effectiveness of budesonide in treating former or current smokers who have bronchial dysplasia
PURPOSE Randomized double-blinded phase II trial to determine the effectiveness of budesonide in treating former or current smokers who have bronchial dysplasia
Detailed Description:
OBJECTIVES I Determine the efficacy of inhaled budesonide on the number and grade of bronchial epithelial dysplastic lesions in former and current smokers II Compare the effect of inhaled budesonide vs placebo in modulating several intermediate biomarkers ie proliferation apoptosis morphometric and methylation markers in this patient population III Correlate the regression of bronchial dysplasia number and grade and improvement in sputum cytology morphometric grade of atypical cells with the modulations in molecular biomarkers in this patient population IV Compare the stability of the chemopreventive effect of these treatment regimens at six months after completion of these regimens in these patients V Compare the safety of these treatment regimens in these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to gender smoking status current vs former and morphometric index no greater than 34 vs greater than 34 Patients are randomized into one of two treatment arms Arm I Patients receive inhaled budesonide twice daily Arm II Patients receive an inhaled placebo twice daily Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity Patients are followed at 7 months and 12 months
PROJECTED ACCRUAL A total of 110 patients 55 per treatment arm will be accrued for this study within 15 months
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to gender smoking status current vs former and morphometric index no greater than 34 vs greater than 34 Patients are randomized into one of two treatment arms Arm I Patients receive inhaled budesonide twice daily Arm II Patients receive an inhaled placebo twice daily Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity Patients are followed at 7 months and 12 months
PROJECTED ACCRUAL A total of 110 patients 55 per treatment arm will be accrued for this study within 15 months
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 |
|---|---|---|---|
| NCI-P00-0147 | None | None | None |
| BCCA-CIC-98-37 | None | None | None |
| UBC-C98-0411 | None | None | None |