REGIONAL BIODISTRIBUTION & KINETICS OF FLONASE

点击翻译按钮获取中文摘要

Hypothesis: the biodistribution and kinetics of the inhaled asthma medication Flonase will be able to be characterized using the novel techniques of PET-MRI and PET-CT overlay. The objective of this study is to quantitatively evaluate the biodistribution of fluticasone in the nasal cavities of normal volunteers as a function of time following nasal administration according to package directions. The study design is single arm, and open label. PET scanning will be performed in the same fashion as was developed and successfully used for a previous study of [11C]triamcinolone acetonide (NasacortAQ). The formulated radio-pharmaceutical will be administered to normal volunteers during PET data acquisition. Fluticasone is an anti-inflammatory corticosteroid which has been approved for nasal inhalation for treatment of allergic rhinitis. It is marketed as a nasal spray under the trade name of Flonase. Previous studies similar to this proposed work have been performed at University Hospitals by this same PET research group since 1993. The studies have shown the feasibility of the PET imaging of inhaled drugs and the effectiveness of the technique of PET-MRI and PET-CT overlay to produce relevant anatomic and kinetic information. The drug biodistribution and kinetics observed in those studies provided an explanation for the long-acting properties of a previously studied nasal inhaler (NasacortAQ), established the low systemic absorption of that drug, discovered previously unknown aspects of the biodistribution, and provided valuable information for evaluation of the drug by the FDA. The current study proposes to carry out essentially the same study to investigate Fluticasone. Qualifying subjects will be asked to report to the PET scanner in the Division of Nuclear Medicine at University Hospitals where a venous catheter will be placed in an arm, for blood sampling during the study. The venous catheter will be used for conventional pharmacokinetic sampling. Immediately after dosing, patients will be positioned in the scan field and undergo dynamic imaging for up to four hours. Subjects will then be brought to the GCRC for completion of pharmacokinetic sampling and observation. The study has been completed. This study has been completed.