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

Completed · Phase 3 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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).

Key facts

Study ID

NCT00112359

Run by

Gilead Sciences

People needed

166

Starts

2005-05-01

Expected to finish

2007-04-01

Last updated by the study team

2011-04-21

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pediatric Breathing Disorders Clinic — Anchorage, Alaska, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Miller Children's Hospital — Long Beach, California, United States
• Children's Hospital, Los Angeles — Los Angeles, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Capital Allergy and Respiratory Disease Center — Sacramento, California, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• University of Florida Health Sciences Center — Gainesville, Florida, United States
• Nemours Children's Clinic, Orlando — Orlando, Florida, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Children's Memorial Hospital / Northwestern University — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Via Christi - St. Francis Regional Medical Center — Wichita, Kansas, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Louisiana State University Health Sciences Center — Shreveport, Louisiana, United States
• Central Maine Pulmonary Associates — Auburn, Maine, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• University of Missouri — Columbia, Missouri, United States
• St. Louis University — St Louis, Missouri, United States
• Children's Lung Specialists — Las Vegas, Nevada, United States
• St. Barnabas Healthcare System — Livingston, New Jersey, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.