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

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is multicenter placebo-controlled study evaluating the safety and efficacy of AI at two dosage levels compared to placebo in CF patients with P. aeruginosa lung infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Collaborator: Salus Pharma, Inc.
• Treatments: Aztreonam

Criteria

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.