Status:
COMPLETED
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
Lead Sponsor:
Gilead Sciences
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief Summary
The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA...
Detailed Description
Patients with CF often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called PA. Treatment with antibiotics can stop or slow down th...
Eligibility Criteria
Inclusion
- CF as diagnosed by:
- Documented sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test; or
- Two well-characterized genetic mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; or
- Abnormal nasal potential difference with accompanying symptoms characteristic of CF.
- PA present in expectorated sputum or throat swab culture at Screening.
- Participants must have received three or more courses of TIS within the previous 12 months.
- Participants on chronic azithromycin must have had no change in regimen in the previous 3 months and must have had a need for TIS and/or additional antipseudomonal therapy since initiation of azithromycin.
- Forced expiratory volume in 1 second (FEV1) between (and including) 25% and 75% predicted at Screening.
- Ability to perform reproducible pulmonary function tests.
- Arterial oxygen saturation (SaO2) greater than or equal to 90% on room air at Screening.
Exclusion
- Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone a day or 20 mg prednisone every other day.
- History of sputum or throat culture swab yielding Burkholderia cepacia in the past 2 years.
- History of daily continuous oxygen supplementation or requirement for more than 2 liters/minute at night.
- Administration of any investigational drug or device within 28 days of Screening (Visit 1) or within 6 half-lives of the investigational drug (whichever was longer).
- Known local or systemic hypersensitivity to monobactam antibiotics.
- Inability to tolerate inhalation of a short acting Beta-2 agonist.
- Changes in antimicrobial, bronchodilator, anti-inflammatory, or corticosteroid medications within 7 days before Screening or between Screening and the next visit.
- Changes in physiotherapy technique or schedule within 7 days before 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 or serum chemistry at Screening (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\] greater than 5 times the upper limit of normal range; Creatinine greater than 2 times the upper limit of normal range).
- Positive pregnancy test at Screening.
- Female of childbearing potential who was lactating or in the opinion of the investigator was not practicing acceptable 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT00104520
Start Date
February 1 2005
End Date
September 1 2006
Last Update
March 11 2011
Active Locations (56)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
3
University of California, San Diego
La Jolla, California, United States
4
Children's Hospital Los Angeles
Los Angeles, California, United States