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Completed

NCT Number: NCT00407264

Randomized Trial of Fluticasone in Bronchial Premalignancy

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

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Key information

Conditions

Bronchogenic Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VU medical center, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluticasone propionate

Drug

Primary outcomes

  1. Reversal of histological abnormality bronchial biopsies at 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Collaborators

  • GlaxoSmithKline
  • The Netherlands Cancer Institute

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2005
First posted
Dec 4, 2006
Registry last updated
Dec 4, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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