A Phase 3, Open-label, Follow-On Study of Multiple Courses of Aztreonam Lysinate for Inhalation (AI) in Cystic Fibrosis Patients (AIR-CF3)

Gilead Sciences64 个研究点分布在 1 个国家目标入组 274 人开始时间: 2005年8月最近更新: 2011年5月19日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Gilead Sciences
入组人数: 274
试验地点: 64
主要终点: Number of Participants Reporting Adverse Events (AEs)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).

详细描述

People with CF often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by PA. Treatment with antibiotics is used to reduce the presence of the bacteria. The antibiotics may be given orally, intravenously, or inhaled as a mist. The purpose of this study was to evaluate whether AZLI, an investigational formulation of the antibiotic aztreonam, is safe in repeated courses in patients with CF and PA.

A course of AZLI treatment in this study comprised 28 days, followed by a 28-day period off treatment. Participants could receive up to 9 courses of AZLI, with a total time on study of up to 18 months. Safety and efficacy results for the 18-month, 9-course period are reported, with efficacy results presented on a by-treatment course basis.

研究设计

研究类型: Interventional
分配方式: Non Randomized
主要目的: Treatment
盲法: None

入排标准

年龄范围: 6 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Compliance with Studies CP-AI-005 (NCT00104520) or CP-AI-007 (NCT00112359) by taking at least 50% of expected study medication.
•Completion of CP-AI-005 or CP-AI-007 or was withdrawn due to need for antipseudomonal antibiotics or for an AE unrelated to study medication tolerance.
•Ability to provide written informed consent/assent prior to initiation of study-related procedures.
•Ability to perform reproducible pulmonary function tests.

排除标准

•Use of any investigational medication or device between the last visit of CP-AI-005 or CP-AI-007 and Visit 1 of this study.
•Concurrent participation in a study of another investigational drug or device.
•Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone/day or 20 mg prednisone every other day.
•History of sputum or throat swab culture yielding Burkholderia cepacia in the previous 2 years.
•History of daily continuous oxygen supplementation or requirement for more than 2 liters/minute at night.
•Inability to tolerate study medication in CP-AI-005 or CP-AI-
•Known local or systemic hypersensitivity to aztreonam.
•Inability to tolerate inhalation of a short acting beta-2 agonist.
•Abnormal renal or hepatic function based on results of most recent test.
•Female of child-bearing potential who was pregnant, lactating, or not (in the opinion of the investigator) practicing an acceptable method of birth control.
•Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would have interfered with participant treatment, assessment, or compliance with the protocol.

结局指标

主要结局

Number of Participants Reporting Adverse Events (AEs)

时间窗: Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug

Participants experiencing at least 1 treatment-emergent AE or at least 1 serious adverse event (SAE) were summarized for the study as a whole. A treatment-emergent AE was any physical or clinical worsening in symptoms or disease experienced by the participant, whether or not the event was considered related to study participation or study procedures. An SAE was any adverse experience that resulted in hospitalization or death. Participants were monitored for AEs and SAEs during all on-treatment and off-treatment intervals throughout the 18-month study period.

Number of Subjects With <15% or ≥15% Decline in Forced Expiratory Volume in 1 Second [FEV1] From Pretreatment to 30 Minutes After Treatment With AZLI

时间窗: Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug

Airway reactivity (percent change in FEV1 from pretreatment to 30 minutes after treatment with AZLI) was assessed at all study visits in which a participant received AZLI treatment. A participant was included in this endpoint if they experienced a decline in FEV1 of ≥15% at any visit in which they received AZLI.

Change in Heart Rate (HR)

时间窗: Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)

HR was recorded at all visits. Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.

Change in Systolic and Diastolic Blood Pressure (BP)

时间窗: Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)

BP was recorded at all visits. Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.

Change in Temperature

时间窗: Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)

Temperature was recorded at all visits. Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.

Change in Respiratory Rate (RR)

时间窗: Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)

RR was recorded at all visits. Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.

Serum Hematology - Concentration of White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets

时间窗: Baseline and end of Course 9 (Week 68)

Serum Hematology - Percent of Differential for Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils