An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística

Gilead Sciences Inc0 个研究点目标入组 274 人开始时间: 2008年1月24日最近更新: 2021年10月8日

适应症

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•Patients with CF who have PA present in an expectorated sputum culture or throat swab at or within 3 months prior to Screening
•Male or female aged 6 years and over
•Patients must have received previous treatment with aerosolized antibiotics without demonstration of drug intolerance
•Changes in azithromycin within 28 days of Screening will be excluded
•Use of inhaled, intravenous (IV) or oral antipseudomonal antibiotics during the 14 days prior to Screening will be excluded
•FEV1 = 75% predicted at Screening
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•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

••Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone a day or 20 mg prednisone every other day
•History of sputum or throat swab culture yielding B. cepacia in the previous 2 years
•Current requirement for daily continuous oxygen supplementation or requirement for more than 2 L/minute at night
•Administration of any investigational drug or device within 28 days of Visit 1 or within 6 half-lives of the investigational drug (whichever is longer)
•Known local or systemic hypersensitivity to monobactam antibiotics
•Known allergies/intolerance to tobramycin
•Inability to tolerate inhalation of a short acting ?2 agonist
•Changes in or initiation of chronic azithromycin treatment within 28 days prior to Visit 1
•Administration of antipseudomonal antibiotics by inhalation, intravenous or oral routes within the 14 days prior to Visit 1
•Changes in antimicrobial, bronchodilator (BD), dornase alfa, or corticosteroid medications within 7 days prior to Visit 1
•Changes in physiotherapy technique or schedule within 7 days prior to Visit 1
•History of lung transplantation
•Abnormal renal or hepatic function or serum chemistry at Visit 1

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