Lung CancerPhase 2NCT00780234
Pioglitazone for Lung Cancer Chemoprevention
A Phase 2 study testing fluorescence bronchoscopy and quantitative high resolution CT scan in people with Lung Cancer and Endobronchial Dysplasia, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
This is a chemoprevention trial evaluating the diabetic agent pioglitazone. Non-diabetic subjects at risk for lung cancer (based on smoking history, lung function testing, and atypical cells in a sputum sample) receive either placebo or pioglitazone and have chest computerized tomography (CAT) scans and examinations… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Endobronchial Dysplasia
- What is being tested?
- fluorescence bronchoscopy and quantitative high resolution CT scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2009to Aug 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current or former smoker (at least 10 pack years);
- One or more of the following:
- Mild or worse sputum atypia
- Airflow Limitation (FEV1/FVC<70% predicted)
- Biopsy proven airway dysplasia
Who cannot join
- myocardial infarction (MI) with ejection fraction < 50%;
- severe/unstable angina;
- history of coronary or peripheral arterial bypass grafting;
- New York Heart Association (NYHA) class III or IV congestive heart failure;
- hypoxemia (less than POX 90 with supplemental oxygen); Diabetes type I or II; severe COPD (GOLD stage III or IV); clinically significant edema requiring diuretic therapy;
- life expectancy < 6 months; history of bladder cancer
- pregnant or breast feeding; inability to give informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, 80220
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
About this study
This is a chemoprevention trial evaluating the diabetic agent pioglitazone. Non-diabetic subjects at risk for lung cancer (based on smoking history, lung function testing, and atypical cells in a sputum sample) receive either placebo or pioglitazone and have chest computerized tomography (CAT) scans and examinations of their airways with a bronchoscope at the start of the trial and after 6 months on treatment. Compensation will be provided to the subject after completing the trial.
Read the detailed description
This trial evaluates the oral peroxisome proliferator-activated receptor gamma (PPARgamma) agonist pioglitazone in a double-blind placebo controlled trial. The high risk current and former smokers qualify based on tobacco exposure, airflow limitation on lung function testing, and sputum cytologic atypia. Subjects have a quantitative high resolution thoracic CT scan and a fluorescent bronchoscopy at study entry and after 6 months on drug or placebo. Biologic samples are collected at both time points. The primary outcome is endobronchial histology and determining if pioglitazone can retard progression. Secondary endpoints related to the PPAR gamma signaling pathway will also be analyzed.
- Conditions
- Lung Cancer, Endobronchial Dysplasia
- Being tested
- fluorescence bronchoscopy, quantitative high resolution CT scan, PIOGLITAZONE VS. PLACEBO 30 mg
- Keywords
- chemoprevention, lung cancer, pioglitazone
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorescence bronchoscopyProcedure or surgery
examination of the central airways with a bronchoscope. Both white light and fluorescent light will be used.
quantitative high resolution CT scanProcedure or surgery
High resolution CT scan of the chest
PIOGLITAZONE VS. PLACEBO 30 mgDrug
Patients will be randomized to receive either pioglitazone or placebo. Pioglitazone hydrochloride, a thiazolidinedione antidiabetic agent and a potent peroxisome proliferator-
activated receptor-gamma agonist. It is FDA approved for the treatment of Type II diabetes. It has been previously administered to non-diabetic subjects. The most common side effect of pioglitazone is fluid retention and modest weight gain. There is a potential risk that pioglitazone may cause an elevation in liver enzymes and more serious hepatotoxicity (rare). There is risk of edema and weight gain associated with pioglitazone therapy. 5% experienced peripheral edema in clinical trials. fluid retention may result in new onset heart failure or exacerbation of existing heart failure. Small risk of hypoglycemia, anemia, myalgia, bone fracture, headache, and macular retinal edema exists. There is insufficient information to confirm its safety in Pregnancy/Breastfeeding. Bladder cancer is more serious but rare.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: pioglitazone | Experimental | Current or former smokers receive 6 months of treatment with pioglitazone Receives: Procedure: fluorescence bronchoscopy; Procedure: quantitative high resolution CT scan; Drug: PIOGLITAZONE VS. PLACEBO 30 mg |
| Arm 2: placebo | Placebo comparator | Current or former smokers receive 6 months of treatment with placebo Receives: Procedure: fluorescence bronchoscopy; Procedure: quantitative high resolution CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month Histology Score
Biopsies were classified into one of the following 8 World Health Organization defined categories to classify the endobronchial lesion and assign a score according to the following scale: 1 = normal bronchial epithelium; 2 = reserve cell hyperplasia; 3 = squamous metaplasia without atypia; 4 = mild dysplasia; 5 = moderate dysplasia; 6 = severe dysplasia; 7 = carcinoma in situ (CIS); and 8 = invasive carcinoma. 1 represents the best outcome and 8 represents the worst outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study startAug 2009
- Primary completionJun 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Robert L. Keith, MD, Principal investigator, VA Eastern Colorado Health Care System, Denver, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780234
- Sponsor's protocol ID
- CLIN-005-08S
- Status last verified
- Apr 2019
- First submitted
- 24 Oct 2008
- Last updated
- 11 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pioglitazone for Lung Cancer Chemoprevention
- ClinicalTrials.gov ID
- NCT00780234
- Acronym / sponsor ID
- CLIN-005-08S
- Conditions
- Lung Cancer, Endobronchial Dysplasia
- Keywords
- chemoprevention, lung cancer, pioglitazone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Aug 2009 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 27 Oct 2008 (estimated)
- Results
- Posted 11 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a chemoprevention trial evaluating the diabetic agent pioglitazone. Non-diabetic subjects at risk for lung cancer (based on smoking history, lung function testing, and atypical cells in a sputum sample) receive either placebo or pioglitazone and have chest computerized tomography (CAT) scans and examinations of their airways with a bronchoscope at the start of the trial and after 6 months on treatment. Compensation will be provided to the subject after completing the trial.
Detailed description
This trial evaluates the oral peroxisome proliferator-activated receptor gamma (PPARgamma) agonist pioglitazone in a double-blind placebo controlled trial. The high risk current and former smokers qualify based on tobacco exposure, airflow limitation on lung function testing, and sputum cytologic atypia. Subjects have a quantitative high resolution thoracic CT scan and a fluorescent bronchoscopy at study entry and after 6 months on drug or placebo. Biologic samples are collected at both time points. The primary outcome is endobronchial histology and determining if pioglitazone can retard progression. Secondary endpoints related to the PPAR gamma signaling pathway will also be analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: pioglitazone | Experimental | Procedure: fluorescence bronchoscopy, Procedure: quantitative high resolution CT scan, Drug: PIOGLITAZONE VS. PLACEBO 30 mgCurrent or former smokers receive 6 months of treatment with pioglitazone |
| Arm 2: placebo | Placebo comparator | Procedure: fluorescence bronchoscopy, Procedure: quantitative high resolution CT scanCurrent or former smokers receive 6 months of treatment with placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current or former smoker (at least 10 pack years);
- One or more of the following:
- Mild or worse sputum atypia
- Airflow Limitation (FEV1/FVC<70% predicted)
- Biopsy proven airway dysplasia
Key exclusion criteria (7 listed)
- myocardial infarction (MI) with ejection fraction < 50%;
- severe/unstable angina;
- history of coronary or peripheral arterial bypass grafting;
- New York Heart Association (NYHA) class III or IV congestive heart failure;
- hypoxemia (less than POX 90 with supplemental oxygen); Diabetes type I or II; severe COPD (GOLD stage III or IV); clinically significant edema requiring diuretic therapy;
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 |
|---|---|---|
| fluorescence bronchoscopyexamination of the central airways with a bronchoscope. Both white light and fluorescent light will be used. | Procedure or surgery | Arm 1: pioglitazone, Arm 2: placebo |
| quantitative high resolution CT scanHigh resolution CT scan of the chest | Procedure or surgery | Arm 1: pioglitazone, Arm 2: placebo |
| PIOGLITAZONE VS. PLACEBO 30 mgPatients will be randomized to receive either pioglitazone or placebo. Pioglitazone hydrochloride, a thiazolidinedione antidiabetic agent and a potent peroxisome proliferator- activated receptor-gamma agonist. It is FDA approved for the treatment of Type II diabetes. It has been previously administered to non-diabetic subjects. The most common side effect of pioglitazone is fluid retention and modest weight gain. There is a potential risk that pioglitazone may cause an elevation in liver enzymes and more serious hepatotoxicity (rare). There is risk of edema and weight gain associated with pioglitazone therapy. 5% experienced peripheral edema in clinical trials. fluid retention may result in new onset heart failure or exacerbation of existing heart failure. Small risk of hypoglycemia, anemia, myalgia, bone fracture, headache, and macular retinal edema exists. There is insufficient information to confirm its safety in Pregnancy/Breastfeeding. Bladder cancer is more serious but rare. | Drug | Arm 1: pioglitazone |
Primary outcome
6-month Histology Score
Time frame: 6 months
Biopsies were classified into one of the following 8 World Health Organization defined categories to classify the endobronchial lesion and assign a score according to the following scale: 1 = normal bronchial epithelium; 2 = reserve cell hyperplasia; 3 = squamous metaplasia without atypia; 4 = mild dysplasia; 5 = moderate dysplasia; 6 = severe dysplasia; 7 = carcinoma in situ (CIS); and 8 = invasive carcinoma. 1 represents the best outcome and 8 represents the worst outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Oral iloprost improves endobronchial dysplasia in former smokersLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Robert L. Keith, MD principal investigator
VA Eastern Colorado Health Care System, Denver, CO
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 fluorescence bronchoscopy and quantitative high resolution CT scan in people with Lung Cancer and Endobronchial Dysplasia, run by VA Office of Research and Development at 2 sites in United States.
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 7 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 11 Apr 2019. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 11 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
6-month Histology Score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2019.