Randomized Trial of Fluticasone in Bronchial Premalignancy | NCT00407264

Studies
Randomized Trial of Fluticasone in Bronchial Premalignancy

NCT00407264

Sponsor

Amsterdam UMC, location VUmc

Status

Completed

Last Update Posted

Dec 4, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

Bronchogenic Carcinoma

Interventions

Fluticasone propionate

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
FLU 00-02

Status Module

Record Verification Date

Nov 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2002

Primary Completion Date

Not provided

Completion Date

Dec 2005

First Submitted Date

Nov 28, 2006

First Submission Date that Met QC Criteria

Nov 29, 2006

First Posted Date

Dec 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2006

Last Update Posted Date

Dec 4, 2006Estimated

Name	Class
GlaxoSmithKline	INDUSTRY
The Netherlands Cancer Institute	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Fluticasone propionate	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reversal of histological abnormality bronchial biopsies at 6 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Egbert F Smit, MD PHD	Amsterdam UMC, location VUmc	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital		Amsterdam		1066CX	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10657955	Background	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.
12711117

ID	Term
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms

ID	Term
D000730	Androstadienes
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473