Randomized Trial of Fluticasone in Bronchial Premalignancy

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: VU University Medical Center
• Collaborators: GlaxoSmithKline; The Netherlands Cancer Institute
• Treatments: Fluticasone; Xhance

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