Aztreonam for Inhalation (AI) in Patients With Cystic Fibrosis & P. Aeruginosa Infection

Inclusion Criteria:

• Written informed consent prior to the performance of any study related procedures.
• 13 years of age and above.
• Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT) or homozygosity for ΔF508 genetic mutation or heterozygosity for two well characterized mutations.
• Ability to perform pulmonary function tests.
• FEV1 ≥ 40% predicted at Visit 1 (Screening).
• SaO2 ≥ 90% at Visit 1 (Screening).
• P. aeruginosa present in sputum at Visit 1 (Screening).
• Ability to expectorate sputum on a daily basis.

Exclusion Criteria:

• Administration of any antibiotic with antipseudomonal activity by any route within 56 days prior to Visit 1 (Screening).
• Administration of any investigational drug or device within 28 days of Visit 1 (Screening) and within 6 half-lives of the investigational drug.
• Oral corticosteroids in doses exceeding 10 mg per day or 20 mg every other day.
• History of sputum culture or throat swab culture yielding B. cepacia in the previous two years.
• Current daily continuous oxygen supplementation or requirement for more than 2 L/min at night.
• Known local or systemic hypersensitivity to monobactam antibiotics.
• Changes in antimicrobial, bronchodilator, anti-inflammatory or corticosteroid medications within 7 days prior to Visit 1 (Screening).
• Changes in physiotherapy technique or schedule within 7 days prior to Visit 1 (Screening).
• History of lung transplantation.
• A chest radiograph at Visit 1 (Screening) or within the previous 90 days of Screening, with abnormalities indicating a significant acute finding (eg, lobar infiltrate and atelectasis, pneumothorax, or pleural effusion).

• Abnormal renal or hepatic function or serum chemistry at Visit 1 (Screening):

  • AST, ALT > 2.5 times upper limit of normal range.
  • Creatinine > 1.5 times upper limit of normal range.
• Positive pregnancy test. All women of childbearing potential will be tested.
• Female of childbearing potential who is lactating or is not practicing acceptable method of birth control (eg, hormonal or barrier methods, or IUD).
• Findings at Visit 1 (Screening) that, in the investigator's opinion, would compromise the safety of the patient or the quality of the study data.