A Phase IIb Trial of Pulmicort Turbuhaler (Budesonide)

This study has been completed.

First Received on September 13, 2005. No Changes Posted

Sponsor:	University of British Columbia
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00175747

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 II Phase III

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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Budesonide

U.S. FDA Resources

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

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:

Lam S, leRiche JC, McWilliams A, Macaulay C, Dyachkova Y, Szabo E, Mayo J, Schellenberg R, Coldman A, Hawk E, Gazdar A. A randomized phase IIb trial of pulmicort turbuhaler (budesonide) in people with dysplasia of the bronchial epithelium. Clin Cancer Res. 2004 Oct 1;10(19):6502-11.

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 February 12, 2012