International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa

Exclusion Criteria

• •Administration of antipseudomonal antibiotics by inhalation, IV, or oral routes (including azithromycin) within 14 days of Screening.
• •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.
• •Administration of any investigational drug or use of any investigational device within 28 days of Screening and within 6 half-lives of the investigational drug (whichever was longer).
• •Known local or systemic hypersensitivity to monobactam antibiotics.
• •Inability to tolerate short-acting bronchodilator use at least three times daily.
• •Changes in protocol-permitted antimicrobial, bronchodilator, anti-inflammatory, or corticosteroid medications within 7 days prior to Screening or between Screening and the next visit.
• •Changes in physiotherapy technique or schedule within 7 days prior to Screening or between Screening and the next visit.
• •History of lung transplantation.
• •A chest x-ray indicating abnormal findings at Screening or within the previous 90 days.
• •Abnormal renal or hepatic function at Screening.
• •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.
• •Use of aerosolized hypertonic saline (except for sputum induction) during the 14 days preceding Visit 1.