EUCTR2007-004277-26-IE进行中（未招募）不适用
An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with CF who have PA present in an expectorated sputum culture or throat swab at or within 3 months prior to Screening
- •Male or female aged ? 6 years
- •Patients must have received previous treatment with aerosolized antibiotics without demonstration of drug intolerance
- •Changes in azithromycin within 28 days of Screening will be excluded
- •Use of inhaled, intravenous (IV) or oral antipseudomonal antibiotics during the 14 days prior to Screening will be excluded
- •FEV1 = 75% predicted at Screening
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- ••Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone a day or 20 mg prednisone every other day
- •History of sputum or throat swab culture yielding B. cepacia in the previous 2 years
- •Current requirement for daily continuous oxygen supplementation or requirement for more than 2 L/minute at night
- •Administration of any investigational drug or device within 28 days of Visit 1 or within 6 half-lives of the investigational drug (whichever is longer)
- •Known local or systemic hypersensitivity to monobactam antibiotics
- •Known allergies/intolerance to tobramycin
- •Inability to tolerate inhalation of a short acting ?2 agonist
- •Changes in or initiation of chronic azithromycin treatment within 28 days prior to Visit 1
- •Administration of antipseudomonal antibiotics by inhalation, intravenous or oral routes within the 14 days prior to Visit 1
- •Changes in antimicrobial, bronchodilator (BD), dornase alfa, or corticosteroid medications within 7 days prior to Visit 1
- •Changes in physiotherapy technique or schedule within 7 days prior to Visit 1
- •History of lung transplantation
- •Abnormal renal or hepatic function or serum chemistry at Visit 1
研究者
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