Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA) (AIR-CF3)

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Cystic Fibrosis

Treatments: Drug: AZLI 75 mg two times a day (BID)/ three times a day (TID)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00128492

CP-AI-006

Details and patient eligibility

About

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).

Full description

People with CF often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by PA. Treatment with antibiotics is used to reduce the presence of the bacteria. The antibiotics may be given orally, intravenously, or inhaled as a mist. The purpose of this study was to evaluate whether AZLI, an investigational formulation of the antibiotic aztreonam, is safe in repeated courses in patients with CF and PA.

A course of AZLI treatment in this study comprised 28 days, followed by a 28-day period off treatment. Participants could receive up to 9 courses of AZLI, with a total time on study of up to 18 months. Safety and efficacy results for the 18-month, 9-course period are reported, with efficacy results presented on a by-treatment course basis.

Enrollment: 274 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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• Completion of CP-AI-005 or CP-AI-007 or was withdrawn due to need for antipseudomonal antibiotics or for an AE unrelated to study medication tolerance.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