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A Phase IIb Trial of Pulmicort Turbuhaler (Budesonide)

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ClinicalTrials.gov Identifier: NCT00175747
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 15, 2005
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Lung Cancer Drug: Inhaled Budesonide 800 µg twice daily Phase 2 Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized Phase IIb Trial of Pulmicort Turbuhaler (Budesonide) in People With Dysplasia of the Bronchial Epithelium
Study Start Date : January 2000
Estimated Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Rate of progression of bronchial dysplasia

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 15, 2005
Last Verified: September 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