NL-OMON50497已完成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 - ALPINE 2
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •* Male or female aged 3 months to less than 18 years
- •* Diagnosis of CF as determined by the 2008 CF Consensus Conference criteria:
- •o Sweat chloride level * 60 mEq/L by quantitative pilocarpine iontophoresis;
- •o or a genotype with 2 identifiable mutations consistent with CF;
- •o 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)
- •* FEV1 * 80% predicted (for subjects * 6 years of age who can reliably perform
- •spirometry assessments)
- •* Clinically stable with no evidence of either acute significant respiratory
- •symptoms that would require administration of 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 or intolerance to inhaled short acting *2 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; for subjects on a stable regimen
- •of hypertonic saline (28 days on/28 days off), beginning or ending a cycle of
- •hypertonic saline is allowed
- •* Changes in physiotherapy technique or schedule within 7 days prior to
- •* Abnormal renal or hepatic function results at most recent test within the
- •previous 12 months, defined as
- •o AST or ALT >5 times upper limit of normal (ULN), or
- •o 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
研究者
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