Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Budesonide in Treating Former and Current Smokers With Bronchial Dysplasia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Prevention	Completed	40 to 74	NCI	BCCA-CIC-98-37 UBC-C98-0411, NCI-P00-0147, NCT00005880

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 (i.e., 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.

Entry Criteria

Disease Characteristics:

Histologically confirmed mild, moderate, or severe bronchial dysplasia 
 More than one suspicious area of abnormal fluorescence on bronchoscopy
  If only one abnormal area, lesion must be greater than 1.5 mm

Current or ex-smokers who have smoked at least 30 pack years (e.g., 1 pack per
day for at least 30 years)

Sputum cells with morphometric index at least 7 by computer-assisted image
analysis

No invasive cancer on bronchoscopy or abnormal chest x-ray suspicious of lung
cancer

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 Not specified

Endocrine therapy:
 At least 6 months since prior oral glucocorticoids (e.g., prednisone)
 At least 6 months since prior inhaled glucocorticoids (e.g., budesonide,
  Beclovent, or Becloforte)

Radiotherapy:
 Not specified

Surgery:
 Not specified

Patient Characteristics:

Age:
 40 to 74

Performance status:
 Not specified

Life expectancy:
 Not specified

Hematopoietic:
 No bleeding disorder

Hepatic:
 Not specified

Renal:
 Not specified

Cardiovascular:
 No unstable angina or congestive heart failure

Pulmonary:
 No active pulmonary tuberculosis
 No acute bronchitis or pneumonia
 No acute or chronic respiratory failure

Other:
 No history of allergy to budesonide or lactose
 No known reaction to lidocaine
 Ability to reliably take medication
 Not pregnant or nursing
 Negative pregnancy test
 Fertile patients must use effective contraception

Expected Enrollment

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 3.4 vs greater than 3.4). 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.

Trial Contact Information

Trial Lead Organizations

British Columbia Cancer Agency - Vancouver Cancer Centre

Stephen Lam, MD, Protocol chair		Ph: 604-675-8089; 800-663-3333

Registry Information
Official Title		A Phase II Trial of Inhaled Budesonide (Pulmicort Turbuhaler) in Persons with Dysplasia of the Bronchial Epithelium
Trial Start Date		2000-07-05
Registered in ClinicalTrials.gov		NCT00005880
Date Submitted to PDQ		2000-05-01
Information Last Verified		2007-07-30

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