EUCTR2016-002749-42-BE进行中（未招募）1 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 - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
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
- •1) Male or female aged 3 months to less than 18 years at screening
- •2) Diagnosis of CF as determined by the 2008 CF Consensus Conference criteria
- •3) 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)
- •4) FEV1 = 80% predicted
- •5) Clinically stable with no evidence of acute significant respiratory symptoms that would require administration of IV antipseudomonal antibiotics, oxygen supplementation, or hospitalization
- •6) A negative serum pregnancy test is required for female subjects of child bearing potential who have a positive urine pregnancy test at screening
- •7) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- •8) Lactating females must agree to discontinue nursing before administration of study drug
- •9) Subjects and/or parent/guardian must be able to give written informed consent prior to study related procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 140
- •F.1.2 Adults (18-64 years) no
- •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
- •1) Use of IV or inhaled antipseudomonal antibiotics within 2 years of Screening
- •2) Use of oral antipseudomonal antibiotics for a respiratory event within 30 days of study entry (Screening visit)
- •3) History of intolerance to inhaled short acting ß2 agonists
- •4) History of lung transplantation
- •5) Administration of any investigational drug or device within 28 days prior to Screening
- •6) Concurrent use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone per day or 20 mg prednisone every other day
- •7) Current requirement for daily continuous oxygen supplementation or requirement of more than 2 L/minute at night
- •8) Hospitalization for a respiratory event within 30 days prior to Screening
- •9) Changes in antimicrobial, bronchodilator, corticosteroid, dornase alfa, or hypertonic saline medications within 7 days prior to Screening
- •10) Significant changes (per investigators discretion) in physiotherapy technique or schedule within 7 days prior to Screening
- •11) Abnormal hepatic or renal function results at most recent test within the previous 12 months, defined as
- •- AST or ALT >5 times upper limit of normal (ULN), or
- •- Serum creatinine > 2 times ULN for age
- •12) Presence of a condition or abnormality that would, in the opinion of the Investigator, compromise the subject’s safety or the quality of the study data
- •13) Known hypersensitivity to aztreonam, its metabolites, or formulation excipients present in AZLI
- •14) Respiratory cultures performed within 2 years prior to Screening that are positive for ANY Burkholderia spp. or NTM
研究者
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