Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Aztreonam

Criteria

Inclusion Criteria:

• Compliance with Studies CP-AI-005 (NCT00104520) or CP-AI-007 (NCT00112359) by taking at least 50% of expected study medication.

• Completion of CP-AI-005 or CP-AI-007 or was withdrawn due to need for antipseudomonal antibiotics or for an AE unrelated to study medication tolerance.

• Ability to provide written informed consent/assent prior to initiation of study-related procedures.

• Ability to perform reproducible pulmonary function tests.

Exclusion Criteria:

• Use of any investigational medication or device between the last visit of CP-AI-005 or CP-AI-007 and Visit 1 of this study.

• Concurrent participation in a study of another investigational drug or device.

• 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.

• Inability to tolerate study medication in CP-AI-005 or CP-AI-007.

• Known local or systemic hypersensitivity to aztreonam.

• Inability to tolerate inhalation of a short acting beta-2 agonist.

• Abnormal renal or hepatic function based on results of most recent test.

• Female of child-bearing potential who was pregnant, lactating, or not (in the opinion of the investigator) practicing an acceptable method of birth control.

• 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.