Bronchogenic CarcinomaPhase 2NCT00407264
Randomized Trial of Fluticasone in Bronchial Premalignancy
A Phase 2 study testing Fluticasone propionate in people with Bronchogenic Carcinoma, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
Trial summary
The purpose of this study is to assess the efficacy of fluticasone on the development of lung cancer in smokers Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bronchogenic Carcinoma
- What is being tested?
- Fluticasone propionate
- How many people
- 90 participants
- Where
- 2 sitesNetherlands
- Study dates
- Feb 2002to Dec 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
the Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital
Amsterdam, 1066CX
VU medical center
Amsterdam, 1081HV
About this study
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
The purpose of this study is to assess the efficacy of fluticasone on the development of lung cancer in smokers
Read the 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.
- Conditions
- Bronchogenic Carcinoma
- Being tested
- Fluticasone propionate
- Keywords
- bronchial squamous metaplasia, bronchial squamous dysplasia
- Medical subject headings
- Carcinoma, Bronchogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone propionateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startFeb 2002
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bronchogenic CarcinomaStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, The Netherlands Cancer Institute
- Investigators
- Egbert F Smit, MD PHD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407264
- Sponsor's protocol ID
- FPD2001
- Other IDs
- FLU 00-02
- Status last verified
- Nov 2006
- First submitted
- 28 Nov 2006
- Last updated
- 4 Dec 2006
- Results posted
- No
Publications
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.
PubMed 10657955Breuer 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.
PubMed 12711117
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00407264
- Acronym / sponsor ID
- FPD2001
- Conditions
- Bronchogenic Carcinoma
- Keywords
- bronchial squamous metaplasia, bronchial squamous dysplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, The Netherlands Cancer Institute
- Study start
- Feb 2002
- Study completion
- Dec 2005
- First posted
- 4 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone propionate | Drug | – |
Primary outcome
Reversal of histological abnormality bronchial biopsies at 6 months
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2006.
- Background: PubMed 10657955Wattenberg 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.
- Background: PubMed 12711117Breuer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Egbert F Smit, MD PHD principal investigator
Amsterdam UMC, location VUmc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluticasone propionate in people with Bronchogenic Carcinoma, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reversal of histological abnormality bronchial biopsies at 6 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00407264, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2006.