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A Phase IIb Trial of Pulmicort Turbuhaler (Budesonide)

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175747
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose
Studies in animals suggest that inhaled budesonide may prevent the occurrence of lung cancer. We conducted a clinical trial to determine the effects of inhaled budesonide in smokers who had precancerous lesions in the breathing tubes (i.e. bronchial dysplasia.

Condition Intervention Phase
Lung Cancer
Drug: Inhaled Budesonide 800 µg twice daily
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Randomized Phase IIb Trial of Pulmicort Turbuhaler (Budesonide) in People With Dysplasia of the Bronchial Epithelium

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Rate of progression of bronchial dysplasia

Secondary Outcome Measures:
  • Number of pulmonary nodules on thoracic CT scanning and BCL-2 and p53 expression in the bronchial epithelial cells.

Estimated Enrollment: 120
Study Start Date: January 2000
Estimated Study Completion Date: December 2002
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age > 40 years; smoking history of 30 pack-years or more; normal organ function; sputum atypia

Exclusion Criteria:

  • general debility that would prevent completion of 6 month follow-up; existing cancer diagnosis
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00175747

Locations
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
University of British Columbia
National Cancer Institute (NCI)
Investigators
Principal Investigator: Stephen Lam, MD University of British Columbia
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00175747     History of Changes
Other Study ID Numbers: USPHS Grant N01-CN85188
Study First Received: September 13, 2005
Last Updated: September 13, 2005

Keywords provided by University of British Columbia:
dysplasia
lung cancer
chemoprevention

Additional relevant MeSH terms:
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 25, 2017