Randomized Trial of Fluticasone in Bronchial Premalignancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2005-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Bronchogenic Carcinoma

Keywords

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bronchial squamous metaplasia bronchial squamous dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Fluticasone propionate

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Egbert F Smit, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

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the Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital

Amsterdam, , Netherlands

Site Status

VU medical center

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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Wattenberg LW, Wiedmann TS, Estensen RD, Zimmerman CL, Galbraith AR, Steele VE, Kelloff GJ. Chemoprevention of pulmonary carcinogenesis by brief exposures to aerosolized budesonide or beclomethasone dipropionate and by the combination of aerosolized budesonide and dietary myo-inositol. Carcinogenesis. 2000 Feb;21(2):179-82. doi: 10.1093/carcin/21.2.179.

Reference Type BACKGROUND

PMID: 10657955 (View on PubMed)

Breuer RH, Snijders PJ, Sutedja TG, v d Linden H, Risse EK, Meijer CJ, Postmus PE, Smit EF. Suprabasal p53 immunostaining in premalignant endobronchial lesions in combination with histology is associated with bronchial cancer. Lung Cancer. 2003 May;40(2):165-72. doi: 10.1016/s0169-5002(03)00029-1.