Randomized Trial of Fluticasone in Bronchial Premalignancy

November 29, 2006 updated by: Amsterdam UMC, location VUmc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1081HV
        • VU Medical Center
      • Amsterdam, Netherlands, 1066CX
        • the Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reversal of histological abnormality bronchial biopsies at 6 months

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Collaborators

GlaxoSmithKline
The Netherlands Cancer Institute

Investigators

  • Principal Investigator: Egbert F Smit, MD PHD, Amsterdam UMC, location VUmc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

November 28, 2006

First Submitted That Met QC Criteria

November 29, 2006

First Posted (Estimate)

December 4, 2006

Study Record Updates

Last Update Posted (Estimate)

December 4, 2006

Last Update Submitted That Met QC Criteria

November 29, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPD2001
  • FLU 00-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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