A Phase IIb Trial of Pulmicort Turbuhaler (Budesonide)

This study has been completed.
Sponsor:
Collaborator:
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
Endpoint Classification: Efficacy Study
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
Genders Eligible for Study:   Both
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
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
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 26, 2014