NCT01055847已完成2 期
A Blinded, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam for Inhalation (AI) in Cystic Fibrosis Patient With Lung Disease Due to P. Aeruginosa Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 主要终点
- Change in FEV1 from Baseline to Day 14
研究概览
简要总结
This is multicenter placebo-controlled study evaluating the safety and efficacy of AI at two dosage levels compared to placebo in CF patients with P. aeruginosa lung infection.
详细描述
This is multicenter placebo-controlled study evaluating the safety and efficacy of a 14-day treatment of AI at two dosage levels as compared to placebo, given twice daily, in CF patients with P. aeruginosa lung infection, delivered by the eFlow investigational nebulizer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent prior to the performance of any study related procedures.
- •13 years of age and above.
- •Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT) or homozygosity for ΔF508 genetic mutation or heterozygosity for two well characterized mutations.
- •Ability to perform pulmonary function tests.
- •FEV1 ≥ 40% predicted at Visit 1 (Screening).
- •SaO2 ≥ 90% at Visit 1 (Screening).
- •P. aeruginosa present in sputum at Visit 1 (Screening).
- •Ability to expectorate sputum on a daily basis.
排除标准
- •Administration of any antibiotic with antipseudomonal activity by any route within 56 days prior to Visit 1 (Screening).
- •Administration of any investigational drug or device within 28 days of Visit 1 (Screening) and within 6 half-lives of the investigational drug.
- •Oral corticosteroids in doses exceeding 10 mg per day or 20 mg every other day.
- •History of sputum culture or throat swab culture yielding B. cepacia in the previous two years.
- •Current daily continuous oxygen supplementation or requirement for more than 2 L/min at night.
- •Known local or systemic hypersensitivity to monobactam antibiotics.
- •Changes in antimicrobial, bronchodilator, anti-inflammatory or corticosteroid medications within 7 days prior to Visit 1 (Screening).
- •Changes in physiotherapy technique or schedule within 7 days prior to Visit 1 (Screening).
- •History of lung transplantation.
- •A chest radiograph at Visit 1 (Screening) or within the previous 90 days of Screening, with abnormalities indicating a significant acute finding (eg, lobar infiltrate and atelectasis, pneumothorax, or pleural effusion).
- •Abnormal renal or hepatic function or serum chemistry at Visit 1 (Screening):
- •AST, ALT > 2.5 times upper limit of normal range.
- •Creatinine > 1.5 times upper limit of normal range.
- •Positive pregnancy test. All women of childbearing potential will be tested.
- •Female of childbearing potential who is lactating or is not practicing acceptable method of birth control (eg, hormonal or barrier methods, or IUD).
- •Findings at Visit 1 (Screening) that, in the investigator's opinion, would compromise the safety of the patient or the quality of the study data.
研究组 & 干预措施
AI 75 mg
Experimental
Aztreonam for Inhalation 75 mg twice daily
干预措施: Aztreonam for Inhalation (AI) (Drug)
AI 225 mg
Experimental
Aztreonam for Inhalation 225 mg twice daily
干预措施: Aztreonam for Inhalation (AI) (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in FEV1 from Baseline to Day 14
时间窗: 14 Days
次要结局
未报告次要终点
研究者
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