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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Bronchogenic Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Reversal of histological abnormality bronchial biopsies at 6 months

Principal Investigator

Egbert F Smit, MD PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

VU University Medical Center

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

FPD2001

NCT ID:

NCT00407264

Start Date:

February 2002

Completion Date:

December 2005

Related Keywords:

  • Bronchogenic Carcinoma
  • bronchial squamous metaplasia
  • bronchial squamous dysplasia
  • Carcinoma
  • Carcinoma, Bronchogenic

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