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

Lung Inflammation Clinical Trial

Official title:

Noninvasive Quantification of the Pulmonary Anti-inflammatory Effect of Rosiglitazone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174056
• Other study ID #: DDCF-2010060
• Status: Completed
• Phase: Phase 0
• First received: July 30, 2010
• Last updated: April 22, 2014
• Start date: July 2011
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 44 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alveolitis, Extrinsic Allergic
• Inflammation
• Lung Inflammation
• Pneumonia

Intervention

Drug:
• Zileuton
600 mg tablets po QID for 5 days prior to endotoxin, stopping 24 hours after endotoxin instillation
• Pioglitazone placebo
Lactose filled gelatin capsule, size 00, 1 tablet po bid x 2 weeks prior to endotoxin instillation until 24 hours after endotoxin.
• 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.
• Pioglitazone
PPAR-gamma agonist

Locations

Country	Name	City	State
United States	Washington University / Barnes Jewish Hospital	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Doris Duke Charitable Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before and after endotoxin	No
Secondary	Bronchoalveolar lavage (BAL) fluid cell counts	Total and neutrophil cell counts obtained by bronchoalveolar lavage after endotoxin.	After endotoxin	No