Status:
COMPLETED
International 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 a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudom...
Detailed Description
CF patients often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called Pseudomonas aeruginosa (PA). Treatment with antibiotics can ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT00112359
Start Date
May 1 2005
End Date
April 1 2007
Last Update
April 21 2011
Active Locations (53)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States
2
Pediatric Breathing Disorders Clinic
Anchorage, Alaska, United States
3
Phoenix Children's Hospital
Phoenix, Arizona, United States
4
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States