NCT03219164终止3 期
Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects With Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas Aeruginosa (PA) Infection/Colonization
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 149
- 试验地点
- 53
- 主要终点
- Percentage of Participants With Pseudomonas Aeruginosa (PA)-Negative Cultures Through 28 Days Post-Treatment in the 14-Day Treatment Group vs 28-Day Treatment Group
研究概览
简要总结
The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa respiratory tract infection or colonization.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cystic fibrosis (CF) as determined by the 2008 CF Consensus Conference criteria: Sweat chloride level ≥ 60 milliequivalents per liter (mEq/L) by quantitative pilocarpine iontophoresis; or a genotype with 2 identifiable mutations consistent with CF; or an abnormal nasal transepithelial potential difference (NPD), and 1 or more clinical features consistent with CF
- •Documented new onset of positive respiratory tract culture for PA within 30 days of screening defined as either first lifetime documented PA-positive culture, or PA recovered after at least a 2-year history of PA-negative respiratory cultures (at least 2 cultures per year)
- •Forced expiratory volume in one second (FEV1) ≥ 80% predicted (for subjects ≥ 6 years of age who can reliably perform spirometry assessments)
- •Clinically stable with no evidence of acute significant respiratory symptoms that would require administration of intravenous (IV) antipseudomonal antibiotics, oxygen supplementation, or hospitalization
排除标准
- •Use of IV or inhaled antipseudomonal antibiotics within 2 years of screening
- •Use of oral antipseudomonal antibiotics for a respiratory event within 30 days of study entry (screening visit)
- •History of intolerance to inhaled short acting β2 agonists
- •History of lung transplantation
- •Current requirement for daily continuous oxygen supplementation or requirement of more than 2 L/minute at night
- •Hospitalization for a respiratory event within 30 days prior to screening
- •Changes in bronchodilator, corticosteroid, dornase alfa, or hypertonic saline medications within 7 days prior to screening.
- •Significant changes (per investigators discretion) in physiotherapy technique or schedule within 7 days prior to screening
- •Abnormal renal or hepatic function results at most recent test within the previous 12 months, defined as Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (ULN), or Serum creatinine > 2 times ULN for age
- •Presence of a condition or abnormality that would compromise the subject's safety or the quality of the study data, in the opinion of the Investigator
- •Known hypersensitivity to aztreonam, its metabolites, or formulation excipients in AZLI
- •Respiratory cultures performed within 24 months prior to screening that are positive for ANY Burkholderia spp. or Non-tuberculous mycobacteria (NTM)
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
AZLI + Placebo
Experimental
75 mg/ml of aztreonam will be administered thrice daily (TID) for 14 days followed by placebo to match (PTM) aztreonam TID for 14 days.
干预措施: AZLI (Drug)
AZLI + Placebo
Experimental
75 mg/ml of aztreonam will be administered thrice daily (TID) for 14 days followed by placebo to match (PTM) aztreonam TID for 14 days.
干预措施: Placebo (Drug)
AZLI
Experimental
75 mg/ml of aztreonam will be administered TID for 28 days.
干预措施: AZLI (Drug)
结局指标
主要结局
Percentage of Participants With Pseudomonas Aeruginosa (PA)-Negative Cultures Through 28 Days Post-Treatment in the 14-Day Treatment Group vs 28-Day Treatment Group
时间窗: 28 days post treatment (Weeks 4 to 6 for the 14 Day treatment group and Weeks 4 to 8 for the 28 Day treatment group)
次要结局
- Percentage of Participants With PA-negative Cultures Through 28 Days Post-Treatment in the 14-Day Treatment Group vs Historical Pooled Data for PA Eradication at 28 Days Post-Treatment in Participants Treated With Tobramycin Nebulizer Solution (TNS)(28 days post treatment (Weeks 4 to 6 for the 14 Day treatment group))
- Time to PA Recurrence for a Sub-Group of Participants Matching the Population in the TNS ELITE Study Over a 108-Week Post-Treatment Follow-up Period(Last dose date of AZLI up to Week 112)
- Time From Primary Eradication to PA Recurrence Over a 108-Week Post-Treatment Follow-up Period(Last dose date of AZLI up to Week 112)
研究者
研究点 (53)
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