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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00407264

Enrollment

Registered

2006-12-04

Start date

2002-02-28

Completion date

2005-12-31

Last updated

2006-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchogenic Carcinoma

Keywords

bronchial squamous metaplasia, bronchial squamous dysplasia

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.

Interventions

DRUGFluticasone propionate

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Reversal of histological abnormality bronchial biopsies at 6 months	—

Secondary

Measure	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	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026