TRIAL EVALUATING AZTREONAM LYSINATE FOR INHALATION IN CF PTS WITH AIR-CF1

试验评估用 AIR-CF1 吸入赖氨酸氨曲南用于 CF PTS 的效果

• 批准号: 7603496
• 负责人: RONALD GIBSON
• 金额: $ 0.04万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603496
• 关键词: Aminoglycoside Antibiotics; Aminoglycoside resistance; Aminoglycosides; Anti-Bacterial Agents; Antibiotic Therapy; Antibiotics; Aztreonam; Bacteria; Bacterial Antibiotic Resistance; Breathing; Bronchodilator Agents; Chronic; Computer Retrieval of Information on Scientific Projects Database; Controlled Clinical Trials; Cystic Fibrosis; Deposition; Development; Dose; Double-Blind Method; Drug Formulations; Enrollment; Funding; Gentamicins; Grant; Infection; Institution; Lung; Lung diseases; Patients; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Placebo Control; Pseudomonas; Pseudomonas aeruginosa; Randomized; Range; Research; Research Personnel; Resources; Respiratory physiology; Safety; Source; Time; Tobramycin; United States National Institutes of Health; cystic fibrosis patients; day; improved; killings; treatment duration

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Patients with cystic fibrosis (CF) often have chronic lung infections. Long-term antibiotic treatment makes the development of bacterial resistance to antibiotics a significant concern for CF doctors. The development of new antibiotics or formulations is very important for the treatment of patients with CF. Aztreonam is an approved antibiotic with antibacterial activity similar to that of aminoglycoside antibiotics. When given intravenously, it has been shown to be safe and efficacious for treatment of CF lung infections. A new formulation of aztreonam, Aztreonam Lysinate for Inhalation (AI), has been developed as an option for treatment of pulmonary infections. Although aztreonam's range of activity is similar to that of tobramycin and gentamicin, aztreonam kills bacteria through a different mechanism than aminoglycosides. Thus, aztreonam should not contribute to the emergence of aminoglycoside-resistant bacteria. A phase I study and phase II study of AI in stable patients with CF have been completed with a total enrollment of approximately 100 patients. AI appeared to be safe and well-tolerated, resulted in a significant killing of Pseudomonas bacteria, and improved lung function after 7 and 14 days of treatment with the 75 mg dose of AI nebulized two times a day for 14 days. The results also suggested that the use of bronchodilators may improve AI deposition into the lungs. This phase III, double-blind, multicenter, multinational, randomized, placebo-controlled clinical trial evaluated the safety and efficacy of a 28-day treatment with AI in CF patients with lung disease due to Pseudomonas aeruginosa infection.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 囊性纤维化（CF）患者通常患有慢性肺部感染。 长期抗生素治疗使细菌对抗生素的耐药性的发展成为CF医生的一个重要问题。 开发新的抗生素或制剂对于CF患者的治疗非常重要。氨曲南是一种批准的抗生素，其抗菌活性与氨基糖苷类抗生素相似。当静脉内给药时，它已被证明是安全和有效的CF肺部感染的治疗。一种新的氨曲南制剂，氨曲南赖氨酸吸入剂（AI），已被开发为治疗肺部感染的一种选择。虽然氨曲南的活性范围与妥布霉素和庆大霉素相似，但氨曲南通过与氨基糖苷类不同的机制杀死细菌。 因此，氨曲南不应该有助于氨基糖苷类耐药菌的出现。 在稳定的CF患者中进行的AI I期研究和II期研究已完成，共入组约100例患者。 AI似乎是安全和耐受性良好的，导致假单胞菌的显着杀死，并改善肺功能后，7和14天的治疗与75毫克剂量的AI雾化，每天两次，共14天。 结果还表明，使用支气管扩张剂可能会改善AI沉积到肺部。 这项III期、双盲、多中心、多国、随机、安慰剂对照临床试验评价了在因铜绿假单胞菌感染而患有肺部疾病的CF患者中使用AI治疗28天的安全性和疗效。