Randomized Trial of Fluticasone in Bronchial Premalignancy
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
2 other identifiers
interventional
90
1 country
2
Brief Summary
The purpose of this study is to assess the efficacy of fluticasone on the development of lung cancer in smokers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2002
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 28, 2006
CompletedFirst Posted
Study publicly available on registry
December 4, 2006
CompletedDecember 4, 2006
November 1, 2006
November 28, 2006
November 29, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reversal of histological abnormality bronchial biopsies at 6 months
Secondary Outcomes (3)
Reversal of suprabasal p53 staining at 6 months
Reversal of elevated hTERT mRNA levels at 6 months
Reversal of increased KI-67 at 6 months
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amsterdam UMC, location VUmclead
- GlaxoSmithKlinecollaborator
- The Netherlands Cancer Institutecollaborator
Study Sites (2)
the Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital
Amsterdam, 1066CX, Netherlands
VU medical center
Amsterdam, 1081HV, Netherlands
Related Publications (2)
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.
PMID: 10657955BACKGROUNDBreuer 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.
PMID: 12711117BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Egbert F Smit, MD PHD
Amsterdam UMC, location VUmc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 28, 2006
First Posted
December 4, 2006
Study Start
February 1, 2002
Study Completion
December 1, 2005
Last Updated
December 4, 2006
Record last verified: 2006-11