Randomized Trial of Fluticasone in Bronchial Premalignancy
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Purpose
The purpose of this study is to assess the efficacy of fluticasone on the development of lung cancer in smokers
| Condition | Intervention | Phase |
|---|---|---|
|
Bronchogenic Carcinoma |
Drug: Fluticasone propionate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Prevention |
| 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 |
- Reversal of histological abnormality bronchial biopsies at 6 months
- 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
| Estimated Enrollment: | 90 |
| Study Start Date: | February 2002 |
| Estimated Study Completion Date: | December 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Netherlands | |
| VU medical center | |
| Amsterdam, Netherlands, 1081HV | |
| the Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital | |
| Amsterdam, Netherlands, 1066CX | |
| Principal Investigator: | Egbert F Smit, MD PHD | VU University Medical Center |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00407264 History of Changes |
| Other Study ID Numbers: | FPD2001, FLU 00-02 |
| Study First Received: | November 28, 2006 |
| Last Updated: | November 29, 2006 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by VU University Medical Center:
|
bronchial squamous metaplasia bronchial squamous dysplasia |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Bronchogenic Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
Fluticasone Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013