Evaluation of Rosiglitazone Anti-inflammatory Effect With FDG-PET Imaging
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|ClinicalTrials.gov Identifier: NCT01174056|
Recruitment Status : Completed
First Posted : August 3, 2010
Last Update Posted : April 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Lung Inflammation||Drug: Zileuton Drug: Pioglitazone placebo Drug: Zileuton placebo Drug: Pioglitazone||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Factorial Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Noninvasive Quantification of the Pulmonary Anti-inflammatory Effect of Rosiglitazone|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Experimental: Pioglitazone+zileuton placebo
Pioglitazone 45 mg qD for 2 weeks plus Sugar pill q6hr for 5 days
Drug: Zileuton placebo
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.Drug: Pioglitazone
Other Name: Actos
Experimental: Zileuton+pioglitazone placebo
Sugar pill qD for 2 weeks plus Zileuton 600 mg q6hr for 5 days
600 mg tablets po QID for 5 days prior to endotoxin, stopping 24 hours after endotoxin instillation
Other Name: ZyfloDrug: Pioglitazone placebo
Lactose filled gelatin capsule, size 00, 1 tablet po bid x 2 weeks prior to endotoxin instillation until 24 hours after endotoxin.
Sham Comparator: Pioglitazone placebo+zileuton placebo
Sugar pill qD for 2 weeks plus Sugar pill q6hr for 5 days
Drug: Pioglitazone placebo
Lactose filled gelatin capsule, size 00, 1 tablet po bid x 2 weeks prior to endotoxin instillation until 24 hours after endotoxin.Drug: Zileuton placebo
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.
- 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.
- Bronchoalveolar lavage (BAL) fluid cell counts [ Time Frame: After endotoxin ]Total and neutrophil cell counts obtained by bronchoalveolar lavage after endotoxin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174056
|United States, Missouri|
|Washington University / Barnes Jewish Hospital|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Delphine L Chen, MD||Washington University School of Medicine|