Randomized Trial of Fluticasone in Bronchial Premalignancy - Tabular View

Tracking Information

First Received Date ^ICMJE

November 28, 2006

Last Updated Date

November 29, 2006

Start Date ^ICMJE

February 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Reversal of histological abnormality bronchial biopsies at 6 months

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00407264 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Reversal of suprabasal p53 staining at 6 months
Reversal of elevated hTERT mRNA levels at 6 months
Reversal of increased KI-67 at 6 months

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Randomized Trial of Fluticasone in Bronchial Premalignancy

Official Title ^ICMJE

The Influence of Fluticasone Inhalation on Intermediate Markers of Carcinogenesis in the Bronchial Epithelium of a High Risk Population : A Double Blind Placebo-Controlled Randomised Phase II Study

Brief Summary

The purpose of this study is to assess the efficacy of fluticasone on the development of lung cancer in smokers

Detailed Description

Bronchial epithelium exposed to cigarette smoke undergoes a series of histological changes that may ultimately lead to invasive cancer. In rats exposed to cigarette smoke inhaled corticosteroids reduce the number of lung tumors. The purpose of this study is to assess the efficacy of fluticasone on premalignant lesions in volunteers with a smoking history of >10 pack-years and patients cured of head and neck cancer or lung cancer. Participants are screened for premalignant lesions by bronchoscopy and if these are present randomised to receive a powder inhalation device containing either fluticasone 500 μg or a placebo. After 6 months, biopsies are taken from the same locations. Efficacy of treatment is assessed by reversal of metaplasia/dysplasia; secondary end-points are reversal of increased p53 immunoreactivity and hTERT expression.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Bronchogenic Carcinoma

Intervention ^ICMJE

Drug: Fluticasone propionate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

signed informed consent
age over 18
metaplasia index > 15%
over 25 pack years smoking history or history of lung- or head&neck cancer
male/female of non-childbearing potential or using approved contraception

Exclusion Criteria:

use of inhaled/systemic corticosteroid drugs in the preceding 12 months
contraindications for bronchoscopy/use of fluticasone
major illness
Baseline FEV1<1000ml
Previous participation in clinical study
nodules > 1cm on CT

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00407264

Responsible Party

Study ID Numbers ^ICMJE

FPD2001, FLU 00-02

Study Sponsor ^ICMJE

VU University Medical Center

Collaborators ^ICMJE

GlaxoSmithKline
The Netherlands Cancer Institute

Investigators ^ICMJE

Principal Investigator:

Egbert F Smit, MD PHD

VU University Medical Center

Information Provided By

VU University Medical Center

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP