Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa

Exclusion Criteria

• •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 beta 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 Randomization/Visit 2
• •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, defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 5 times upper limit of normal range (ULN) or creatinine \> 2 times ULN
• •Positive pregnancy test at Visit 1; all women of childbearing potential will be tested
• •Female of childbearing potential who is lactating or is not (in the opinion of the investigator) practicing an acceptable method of birth control; female subjects who utilize hormonal contraceptives as one of their birth control methods must have used the same method for at least 3 months before study dosing
• •Any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patient treatment, assessment, or compliance with the protocol