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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (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:

• 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.