NCT00175747

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_2 lung-cancer

Timeline
Completed

Started Jan 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

September 15, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Lung Cancer

Keywords

dysplasialung cancerchemoprevention

Outcome Measures

Primary Outcomes (1)

  • Rate of progression of bronchial dysplasia

Secondary Outcomes (1)

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

Interventions

Inhaled Budesonide 800 µg twice dailyDRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • general debility that would prevent completion of 6 month follow-up; existing cancer diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Related Publications (1)

  • 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. doi: 10.1158/1078-0432.CCR-04-0686.

    PMID: 15475437RESULT

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Stephen Lam, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

January 1, 2000

Study Completion

December 1, 2002

Last Updated

September 15, 2005

Record last verified: 2005-09

Locations

CA(1)