Evaluating lung deposition and pharmacokinetics after controlled inhalation of a radiotracer containing tobramycin aerosol in patients with Cystic Fibrosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
aube, B.L., Jashnani, R., Dalby, R.N. et al. Targeting aerosol deposition in patients with cystic fibrosis. Effects of alterations in particle size and inspiratory flow rate. Chest 2000; 118:1069-1076.
Le Brun, P.P.H., Vinks, A.A.T.M.M., et al.. “Can tobramycin inhalation be improved with a jet nebulizer?” Ther Drug Mon.1999; 21:618-24.
Foster, W.M., Stetkiewicz, P.T., Freed, A.N.J. Retention of soluble 99mTc-DTPA in the human lung: 24-h postdeposition. Appl. Physiol.1997; 82:1378-1382.
Eberl, S., Chan, H.K., Daviskas, E., SPECT imaging for radioaerosol deposition and clearance studies. J. Aerosol Med. 2006; 19:8-20.
Touw, D.J., Graaf, A.I. de, Goede, P.N.F.C. de. Evaluation of a fluorescence polarographic immunoassay with increased sensitivity for measurement of low concentrations of tobramycin in serum. Ther Drug Mon 1996; 18:189-193.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Clinical diagnosis of CF and a positive sweat test or two CF related mutations;
- •2. Adult patients aged 18 years and older;
排除标准
- •1. Pregnancy or lactation, women of childbearing potential must maintain effective contraception during the treatment period;
- •2. Acute exacerbation of pulmonary infection;