Randomized Trial of Fluticasone in Bronchial Premalignancy

Bronchogenic Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00407264
• Other study ID #: FPD2001
• Secondary ID: FLU 00-02
• Status: Completed
• Phase: Phase 2
• First received: November 28, 2006
• Last updated: November 29, 2006
• Start date: February 2002
• Est. completion date: December 2005

Study information

• Verified date: November 2006
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bronchogenic Carcinoma
• Carcinoma, Bronchogenic

Intervention

Drug:
• Fluticasone propionate

Locations

Country	Name	City	State
Netherlands	the Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital	Amsterdam
Netherlands	VU medical center	Amsterdam

Sponsors (3)

Lead Sponsor	Collaborator
VU University Medical Center	GlaxoSmithKline, The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reversal of histological abnormality bronchial biopsies at 6 months
Secondary	Reversal of suprabasal p53 staining at 6 months
Secondary	Reversal of elevated hTERT mRNA levels at 6 months
Secondary	Reversal of increased KI-67 at 6 months