NCT01404234已完成3 期
Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa (PA) in the Lower Airways
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 29
- 主要终点
- Percentage of Participants Who Discontinued Study Drug Due to Safety or Tolerability Reasons
研究概览
简要总结
This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily, each followed by 28 days off AZLI. The total treatment duration was to be 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CF as determined by the 1997 CF Consensus Conference criteria:
- •Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR
- •Abnormal nasal transepithelial potential difference (NPD) test OR
- •A genotype with 2 identifiable mutations consistent with CF AND
- •One or more clinical features consistent with CF.
- •Documented positive lower respiratory tract culture for PA at the screening visit plus two documented positive lower respiratory tract cultures for PA within 12 months prior to study entry (must have been a minimum 3 months apart.)
- •Clinically stable with no evidence of significant respiratory symptoms or, if obtained for clinical evaluation, no chest radiograph findings at screening that would have required administration of IV antipseudomonal antibiotics, oxygen supplementation, or hospitalization.
排除标准
- •Use of IV or inhaled antipseudomonal antibiotics within 14 days of study entry
- •Presence of a condition or abnormality that would have compromised the participant's safety or the quality of study data, in the opinion of the investigator
- •History of sputum or throat swab culture yielding Burkholderia spp. within 2 years prior to screening visit
- •History of hypersensitivity/adverse reaction to aztreonam
- •History of hypersensitivity/adverse reaction to beta-agonists
- •History of lung transplantation
- •Administration of any investigational drug or device within 30 days prior to screening visit or within 6 half-lives of the investigational drug (whichever was longer)
- •Hospitalization for pulmonary-related illness within 28 days prior to screening visit
- •Changes in or initiation of chronic azithromycin treatment within 28 days prior to screening visit
- •Changes in or initiation of hypertonic saline treatment within 7 days prior to screening visit; for subjects on a stable regimen of hypertonic saline (28 days on/28 days off), beginning or ending a cycle of hypertonic saline was allowed
- •Changes in antimicrobial, bronchodilator (BD), corticosteroid or dornase alfa medications within 7 days prior to screening visit;
- •Changes in physiotherapy technique or schedule within 7 days prior to screening visit
- •Abnormal renal or hepatic function results at most recent test within the previous 90 days
研究组 & 干预措施
Open-label AZLI
Experimental
Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment.
干预措施: AZLI (Drug)
结局指标
主要结局
Percentage of Participants Who Discontinued Study Drug Due to Safety or Tolerability Reasons
时间窗: Baseline to Day 168
Participants who discontinued study drug due to safety or tolerability reasons were defined as those with "Adverse Event (AE)/Safety or Tolerability" on the Study Drug Completion electronic case report form as the reason for early discontinuation. The 95% confidence interval (CI) was calculated using the exact binomial method.
次要结局
- Percentage of Participants Hospitalized at Least Once Due to a Respiratory Event(Baseline to Day 168)
- Adverse Event Rates Adjusted for Study Duration(Baseline to Day 168)
- Percentage of Participants With Pulmonary Exacerbations(Baseline to Day 168)
- Time to Pulmonary Exacerbation(Baseline to Day 168)
- Percentage of Participants With Study-drug Induced Bronchospasm(Pretreatment at Baseline to 30 minutes following treatment)
- Change From Baseline in FEV1 % Predicted in Subjects Aged ≥ 6 Years(Baseline to Day 28, 84, and 140)
- Change From Baseline in CFQ-R Respiratory Symptoms Scale (RSS) Score in Subjects Aged ≥ 6 Years(Baseline to Day 28, 84, and 140)
- Change in Pseudomonas Aeruginosa (PA) Sputum Density(Baseline to Day 28, 84, and 140)
- Percentage of Participants Who Used Additional (Non-study) Antipseudomonal Antibiotics(Baseline to Day 168)
- Number of Days Participants Were Hospitalized Due to a Respiratory Event(Baseline to Day 168)
研究者
研究点 (29)
Loading locations...
相似试验
已完成
3 期
Second Open Label Extension to Bridging Study CTBM100C2303Pulmonary InfectionsPseudomonas AeruginosaNCT01069705Novartis Pharmaceuticals49
已完成
3 期
Open Label Extension to Bridging Study CTBM100C2303Pseudomonas AeruginosaCystic FibrosisNCT00982930Novartis Pharmaceuticals55
已完成
2 期
Aztreonam Lysine for Pseudomonas Infection Eradication StudyCystic FibrosisNCT01375049Gilead Sciences105
已完成
3 期
Preventive Effectiveness, Safety and Immunogenicity of a Allantoic Split Inactivated Seasonal Influenza VaccineHuman InfluenzaNCT03572491Research Institute for Biological Safety Problems2,000
已完成
3 期
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 YearsHealthy SubjectsNCT00761631Pfizer1,200