Randomized Trial of Fluticasone in Bronchial Premalignancy - Full Text View

Sponsor:	VU University Medical Center
Collaborators:	GlaxoSmithKline The Netherlands Cancer Institute
Information provided by:	VU University Medical Center
ClinicalTrials.gov Identifier:	NCT00407264

Purpose

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

Condition	Intervention	Phase
Bronchogenic Carcinoma	Drug: Fluticasone propionate	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Fluticasone propionate Fluticasone

U.S. FDA Resources

Further study details as provided by VU University Medical Center:

Primary Outcome Measures:

Reversal of histological abnormality bronchial biopsies at 6 months

Secondary Outcome Measures:

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

Estimated Enrollment:	90
Study Start Date:	February 2002
Estimated Study Completion Date:	December 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407264

Locations

Netherlands
VU medical center
Amsterdam, Netherlands, 1081HV
the Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066CX

Sponsors and Collaborators

VU University Medical Center

GlaxoSmithKline

The Netherlands Cancer Institute

Investigators

Principal Investigator:

Egbert F Smit, MD PHD

VU University Medical Center

More Information

Publications:

Wattenberg LW, Wiedmann TS, Estensen RD, Zimmerman CL, Galbraith AR, Steele VE, Kelloff GJ. Chemoprevention of pulmonary carcinogenesis by brief exposures to aerosolized budesonide or beclomethasone dipropionate and by the combination of aerosolized budesonide and dietary myo-inositol. Carcinogenesis. 2000 Feb;21(2):179-82.

Breuer RH, Snijders PJ, Sutedja TG, v d Linden H, Risse EK, Meijer CJ, Postmus PE, Smit EF. Suprabasal p53 immunostaining in premalignant endobronchial lesions in combination with histology is associated with bronchial cancer. Lung Cancer. 2003 May;40(2):165-72.

Study ID Numbers:	FPD2001, FLU 00-02
Study First Received:	November 28, 2006
Last Updated:	November 29, 2006
ClinicalTrials.gov Identifier:	NCT00407264 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by VU University Medical Center:

bronchial squamous metaplasia
bronchial squamous dysplasia

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Thoracic Neoplasms
Respiratory System Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Physiological Effects of Drugs
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Autonomic Agents
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Fluticasone
Peripheral Nervous System Agents
Carcinoma, Bronchogenic
Dermatologic Agents
Bronchodilator Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009