Status:
COMPLETED
Randomized Trial of Fluticasone in Bronchial Premalignancy
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
GlaxoSmithKline
The Netherlands Cancer Institute
Conditions:
Bronchogenic Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy of fluticasone on the development of lung cancer in smokers
Detailed 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 reduc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00407264
Start Date
February 1 2002
End Date
December 1 2005
Last Update
December 4 2006
Active Locations (2)
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1
the Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066CX
2
VU medical center
Amsterdam, Netherlands, 1081HV