Randomized Trial of Fluticasone in Bronchial Premalignancy

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
The Netherlands Cancer Institute
Information provided by:
VU University Medical Center
ClinicalTrials.gov Identifier:
NCT00407264
First received: November 28, 2006
Last updated: November 29, 2006
Last verified: November 2006
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
the Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066CX
VU medical center
Amsterdam, Netherlands, 1081HV
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:
ClinicalTrials.gov Identifier: NCT00407264     History of Changes
Other Study ID Numbers: FPD2001, FLU 00-02
Study First Received: November 28, 2006
Last Updated: November 29, 2006
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:
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Fluticasone
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014