Lung InflammationEarly Phase 1NCT01174056
Evaluation of Rosiglitazone Anti-inflammatory Effect With FDG-PET Imaging
A Early Phase 1 study testing Zileuton and Pioglitazone in people with Lung Inflammation, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this research study is to gain understanding of the basic responses of the lung to inflammation and specifically if a certain medication can reduce the inflammation alone or in combination with another. Read more about this study
- Who is it for?
- Ages 19 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Inflammation
- What is being tested?
- Zileuton and Pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Mar 2014
- Phase
- Early Phase 1
- 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 19 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy man or woman, any race or ethnicity, age 19 - 44 years old
- Screening FEV1 and FVC > 90% of predicted
- Screening oxygen saturation by pulse oximetry >97% on room air
- Capable of lying still and supine within the PET/CT scanner for ~1.5 hours
- Capable of following instructions for breathing protocol during CT portion of PET/CT
- Able and willing to give informed consent
- BMI < 35
Who cannot join
- Pregnancy (confirmed by qualitative urine hCG pregnancy test)
- Lactation
- Active menstruation
- History of cardiopulmonary disease
- Currently taking any prescription medications
- History of tobacco use or illicit drug use within the past year
Show all 15Show fewer
- Presence of implanted electronic medical device
- Enrollment in another research study of an investigational drug
- Known allergy to rosiglitazone or zileuton
- Known allergy to both trimethoprim/sulfamethoxazole and amoxicillin
- Known allergy to drugs routinely used during bronchoscopy
- History of chronic active liver disease or acute liver disease within the past 3 months
- SGOT >47 IU/L, SGPT > 53 IU/L, or bilirubin > 1.1 mg/dl
- Inability lie flat for 1.5 hours for PET/CT scans or follow breathing protocol instructions for the CT portion of the PET/CT
- Prior research-related radiation exposure within the past year such that participation in this study would result in exposures that exceed the limits as defined by the FDA RDRC regulations (21 CFR 361.1).
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University / Barnes Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: Noninvasive Quantification of the Pulmonary Anti-inflammatory Effect of Rosiglitazone
The purpose of this research study is to gain understanding of the basic responses of the lung to inflammation and specifically if a certain medication can reduce the inflammation alone or in combination with another. Inflammation is the way our bodies react to irritation or injury, and involves red, warm, and often painful swelling of the affected tissue. "Acute lung injury" involves inflammation that is not specific to one area of the lung and is caused by any one of several conditions: infection, trauma, breathing toxic substances, etc. When lung injury is severe, not enough oxygen can get into the body; this can lead to the need for mechanical support of breathing (mechanical ventilation), problems with brain, heart or other organ function, and in some cases, death.
- Conditions
- Lung Inflammation
- Being tested
- Zileuton, Pioglitazone placebo, Zileuton placebo, Pioglitazone
- Keywords
- Lung inflammation, positron emission tomography, fluorodeoxyglucose, rosiglitazone, zileuton, lung anti-inflammatory therapy
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZileutonDrug
Also called Zyflo
600 mg tablets po QID for 5 days prior to endotoxin, stopping 24 hours after endotoxin instillation
Pioglitazone placeboDrug
Lactose filled gelatin capsule, size 00, 1 tablet po bid x 2 weeks prior to endotoxin instillation until 24 hours after endotoxin.
Zileuton placeboDrug
Placebo tablets provided by manufacturer of Zyflo CR (Cornerstone Therapeutics), 2 tablets po bid x 5 days prior to endotoxin instillation until 24 hours after endotoxin.
PioglitazoneDrug
Also called Actos
PPAR-gamma agonist
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone+zileuton placebo | Experimental | Pioglitazone 45 mg qD for 2 weeks plus Sugar pill q6hr for 5 days Receives: Drug: Zileuton placebo; Drug: Pioglitazone |
| Zileuton+pioglitazone placebo | Experimental | Sugar pill qD for 2 weeks plus Zileuton 600 mg q6hr for 5 days Receives: Drug: Zileuton; Drug: Pioglitazone placebo |
| Pioglitazone placebo+zileuton placebo | Sham comparator | Sugar pill qD for 2 weeks plus Sugar pill q6hr for 5 days Receives: Drug: Pioglitazone placebo; Drug: Zileuton placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ki, measure of FDG uptake
Ki will be measured before and after endotoxin. Primary outcome measure is change in Ki (post- minus pre-endotoxin value) and absolute Ki after endotoxin.
Measured: Before and after endotoxin
Secondary outcomes (1)
Bronchoalveolar lavage (BAL) fluid cell counts
Total and neutrophil cell counts obtained by bronchoalveolar lavage after endotoxin.
Measured: After endotoxin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startJul 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung InflammationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Delphine L Chen, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174056
- Sponsor's protocol ID
- DDCF-2010060
- Status last verified
- Apr 2014
- First submitted
- 30 Jul 2010
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen DL, Huang HJ, Byers DE, Shifren A, Belikoff B, Engle JT, Arentson E, Kemp D, Phillips S, Scherrer DE, Fujiwara H, Spayd KJ, Brooks FJ, Pierce RA, Castro M, Isakow W. The peroxisome proliferator-activated receptor agonist pioglitazone and 5-lipoxygenase inhibitor zileuton have no effect on lung inflammation in healthy volunteers by positron emission tomography in a single-blind placebo-controlled cohort study. PLoS One. 2018 Feb 7;13(2):e0191783. doi: 10.1371/journal.pone.0191783. eCollection 2018.
PubMed 29414995
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Quantification of the Pulmonary Anti-inflammatory Effect of Rosiglitazone
- ClinicalTrials.gov ID
- NCT01174056
- Acronym / sponsor ID
- DDCF-2010060
- Conditions
- Lung Inflammation
- Keywords
- Lung inflammation, positron emission tomography, fluorodeoxyglucose, rosiglitazone, zileuton, lung anti-inflammatory therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Study start
- Jul 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 3 Aug 2010 (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 research study is to gain understanding of the basic responses of the lung to inflammation and specifically if a certain medication can reduce the inflammation alone or in combination with another. Inflammation is the way our bodies react to irritation or injury, and involves red, warm, and often painful swelling of the affected tissue. "Acute lung injury" involves inflammation that is not specific to one area of the lung and is caused by any one of several conditions: infection, trauma, breathing toxic substances, etc. When lung injury is severe, not enough oxygen can get into the body; this can lead to the need for mechanical support of breathing (mechanical ventilation), problems with brain, heart or other organ function, and in some cases, death.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone+zileuton placebo | Experimental | Drug: Zileuton placebo, Drug: PioglitazonePioglitazone 45 mg qD for 2 weeks plus Sugar pill q6hr for 5 days |
| Zileuton+pioglitazone placebo | Experimental | Drug: Zileuton, Drug: Pioglitazone placeboSugar pill qD for 2 weeks plus Zileuton 600 mg q6hr for 5 days |
| Pioglitazone placebo+zileuton placebo | Sham comparator | Drug: Pioglitazone placebo, Drug: Zileuton placeboSugar pill qD for 2 weeks plus Sugar pill q6hr for 5 days |
Who may qualify
- Ages
- 19 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy man or woman, any race or ethnicity, age 19 - 44 years old
- Screening FEV1 and FVC > 90% of predicted
- Screening oxygen saturation by pulse oximetry >97% on room air
- Capable of lying still and supine within the PET/CT scanner for ~1.5 hours
- Capable of following instructions for breathing protocol during CT portion of PET/CT
Key exclusion criteria (15 listed)
- Pregnancy (confirmed by qualitative urine hCG pregnancy test)
- Lactation
- Active menstruation
- History of cardiopulmonary disease
- Currently taking any prescription medications
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 |
|---|---|---|
| ZileutonAlso: Zyflo600 mg tablets po QID for 5 days prior to endotoxin, stopping 24 hours after endotoxin instillation | Drug | Zileuton+pioglitazone placebo |
| Pioglitazone placeboLactose filled gelatin capsule, size 00, 1 tablet po bid x 2 weeks prior to endotoxin instillation until 24 hours after endotoxin. | Drug | Pioglitazone placebo+zileuton placebo, Zileuton+pioglitazone placebo |
| Zileuton placeboPlacebo tablets provided by manufacturer of Zyflo CR (Cornerstone Therapeutics), 2 tablets po bid x 5 days prior to endotoxin instillation until 24 hours after endotoxin. | Drug | Pioglitazone placebo+zileuton placebo, Pioglitazone+zileuton placebo |
| PioglitazoneAlso: ActosPPAR-gamma agonist | Drug | Pioglitazone+zileuton placebo |
Primary outcome
Ki, measure of FDG uptake
Time frame: Before and after endotoxin
Ki will be measured before and after endotoxin. Primary outcome measure is change in Ki (post- minus pre-endotoxin value) and absolute Ki after endotoxin.
1 secondary outcome
Bronchoalveolar lavage (BAL) fluid cell counts
Time frame: After endotoxin
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 23 Apr 2014.
- Derived from this study: PubMed 29414995Chen DL, Huang HJ, Byers DE, Shifren A, Belikoff B, Engle JT, Arentson E, Kemp D, Phillips S, Scherrer DE, Fujiwara H, Spayd KJ, Brooks FJ, Pierce RA, Castro M, Isakow W. The peroxisome proliferator-activated receptor agonist pioglitazone and 5-lipoxygenase inhibitor zileuton have no effect on lung inflammation in healthy volunteers by positron emission tomography in a single-blind placebo-controlled cohort study. PLoS One. 2018 Feb 7;13(2):e0191783. doi: 10.1371/journal.pone.0191783. eCollection 2018.
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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.
Delphine L Chen, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Zileuton and Pioglitazone in people with Lung Inflammation, run by Washington University School of Medicine at 1 site 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 7 inclusion and 15 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 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Ki, measure of FDG uptake (time frame: Before and after endotoxin). 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 NCT01174056, which also lists 1 linked publication.
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 23 Apr 2014.