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

Inclusion Criteria

• Documentation of CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
• Sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT);
• Two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; or
• Abnormal nasal potential difference.
• PA present in expectorated sputum or throat swab culture at Screening.
• FEV1 between (and including) 25% and 75% predicted at Screening.
• Negative pregnancy test at Screening.
• Ability to perform reproducible pulmonary function tests.
• Arterial oxygen saturation (SaO2) greater than or equal to 90% on room air at Screening.
• Ability to provide written informed consent.

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.