Back to resultsRandomized Trial of Fluticasone in Bronchial Premalignancy
Primary Purpose
Bronchogenic Carcinoma
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Fluticasone propionate
Sponsored by
About this trial
This is an interventional prevention trial for Bronchogenic Carcinoma focused on measuring bronchial squamous metaplasia, bronchial squamous dysplasia
Eligibility 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
Sites / Locations
- the Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital
- VU medical center
Outcomes
Primary Outcome Measures
Reversal of histological abnormality bronchial biopsies at 6 months
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00407264
First Posted
November 28, 2006
Last Updated
November 29, 2006
Sponsor
Amsterdam UMC, location VUmc
Collaborators
GlaxoSmithKline, The Netherlands Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT00407264
Brief Title
Randomized Trial of Fluticasone in Bronchial Premalignancy
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Amsterdam UMC, location VUmc
Collaborators
GlaxoSmithKline, The Netherlands Cancer Institute
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchogenic Carcinoma
Keywords
bronchial squamous metaplasia, bronchial squamous dysplasia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
90 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate
Primary Outcome Measure Information:
Title
Reversal of histological abnormality bronchial biopsies at 6 months
Secondary Outcome Measure Information:
Title
Reversal of suprabasal p53 staining at 6 months
Title
Reversal of elevated hTERT mRNA levels at 6 months
Title
Reversal of increased KI-67 at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egbert F Smit, MD PHD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital
City
Amsterdam
ZIP/Postal Code
1066CX
Country
Netherlands
Facility Name
VU medical center
City
Amsterdam
ZIP/Postal Code
1081HV
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
10657955
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. doi: 10.1093/carcin/21.2.179.
Results Reference
background
PubMed Identifier
12711117
Citation
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.
Results Reference
background
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Randomized Trial of Fluticasone in Bronchial Premalignancy
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