NCT01174056

Evaluation of Rosiglitazone Anti-inflammatory Effect With FDG-PET Imaging

Noninvasive Quantification of the Pulmonary Anti-inflammatory Effect of Rosiglitazone

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 19 Years – 44 Years
• Healthy volunteers: Accepted

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. 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

Interventions

Type	Name	Description
DRUG	Zileuton	600 mg tablets po QID for 5 days prior to endotoxin, stopping 24 hours after endotoxin instillation
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.
DRUG	Pioglitazone	PPAR-gamma agonist

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2010-08-03
• Last updated: 2014-04-23

Locations

1 site across 1 country: United States