A Phase II Trial of Inhaled Budesonide (Pulmicort Turbuhaler) in Persons With Dysplasia of the Bronchial Epithelium
40 Years
74 Years
Both
Lung Cancer
Trial Information
A Phase II Trial of Inhaled Budesonide (Pulmicort Turbuhaler) in Persons With Dysplasia of the Bronchial Epithelium
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.
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.
PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this
study within 15 months.
Inclusion 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
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Prevention
Principal Investigator
Stephen Lam, MD
Investigator Role:
Study Chair
Investigator Affiliation:
British Columbia Cancer Agency
Authority:
United States: Federal Government
Study ID:
CDR0000067919
NCT ID:
NCT00005880
Start Date:
July 2000
Completion Date:
Related Keywords:
- Lung Cancer
- non-small cell lung cancer
- small cell lung cancer
- Lung Neoplasms
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