A PHASE 3, PLACEBO-CONTROLLED TRIAL WITH AZTREONAM LYSINATE FOR INHALATION IN CF

赖氨酸氨曲南吸入治疗 CF 的第 3 期安慰剂对照试验

• 批准号: 7603574
• 负责人: RONALD L GIBSON
• 金额: $ 0.02万
• 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/7603574
• 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; Coupled; Cystic Fibrosis; Deposition; Development; Dose; Double-Blind Method; Drug Formulations; Funding; Grant; Infection; Institution; Longevity; Lung; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Placebo Control; Pseudomonas; Randomized; Research; Research Personnel; Resources; Respiratory physiology; Safety; Source; Time; United States National Institutes of Health; cystic fibrosis patients; day; improved; killings; placebo controlled study; 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, coupled with gains in the life span of CF patients, make 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 lung infections in patients with CF. A new formulation of aztreonam, Aztreonam for Inhalation (AI), has been developed as an option for treatment of pulmonary infections. Aztreonam kills bacteria through a different mechanism than aminoglycosides, thus, aztreonam should not contribute to the emergence of aminoglycoside-resistant bacteria. In a phase I study and phase II study of AI in stable patients with CF (n=100), 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 two times a day for 14 days. Results also suggested that the use of bronchodilators may improve AI deposition into the lungs. This phase III double-blind, multicenter, randomized, placebo-controlled clinical trial (n=300) will evaluate the safety and efficacy of two doses of AI over 28 days in 300 patients with CF.

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。长期的抗生素治疗，加上CF患者寿命的延长，使得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。静脉给药时，已证明其对CF患者肺部感染的治疗安全有效。一种新的氨曲南制剂，吸入用氨曲南（AI），已被开发为治疗肺部感染的一种选择。氨曲南通过与氨基糖苷类不同的机制杀死细菌，因此，氨曲南不应导致氨基糖苷类耐药菌的出现。在稳定CF患者（n=100）中进行的AI I期和II期研究中，AI似乎安全且耐受性良好，在75 mg剂量每日两次治疗7天和14天后显著杀死假单胞菌并改善肺功能，持续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、随机、安慰剂对照临床试验（n=300）将在300例CF患者中评估两种剂量AI在28天内的安全性和疗效。