Randomized Trial of Fluticasone in Bronchial Premalignancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00407264
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : December 4, 2006
The Netherlands Cancer Institute
Information provided by:
VU University Medical Center

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

Condition or disease Intervention/treatment Phase
Bronchogenic Carcinoma Drug: Fluticasone propionate Phase 2

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  (Clinical Trial)
Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
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
Study Start Date : February 2002
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Reversal of histological abnormality bronchial biopsies at 6 months

Secondary Outcome Measures :
  1. Reversal of suprabasal p53 staining at 6 months
  2. Reversal of elevated hTERT mRNA levels at 6 months
  3. Reversal of increased KI-67 at 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00407264

the Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066CX
VU medical center
Amsterdam, Netherlands, 1081HV
Sponsors and Collaborators
VU University Medical Center
The Netherlands Cancer Institute
Principal Investigator: Egbert F Smit, MD PHD VU University Medical Center

Publications: Identifier: NCT00407264     History of Changes
Other Study ID Numbers: FPD2001
FLU 00-02
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: December 4, 2006
Last Verified: November 2006

Keywords provided by VU University Medical Center:
bronchial squamous metaplasia
bronchial squamous dysplasia

Additional relevant MeSH terms:
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents