Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF

Completed · Phase 3 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

The primary objective of this study is to evaluate the safety and efficacy of a CAT regimen with aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) in adult and pediatric subjects with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection. Participants will be enrolled in a 28 day TIS run-in phase, and will be eligible for randomization in the comparative phase if they have not received non-study oral antibiotics for a respiratory event, or IV or inhaled antibiotics for any indication between Visits 2 and 3, have not developed a condition requiring hospitalization or other change in clinical status which, in the opinion of the investigator would preclude their ability to continue in the study, and have demonstrated at least 50% TIS compliance. Participants enrolled in the comparative phase will be randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI or placebo for 28 days followed by TIS for 28 days.

Key facts

Study ID

NCT01641822

Run by

Gilead Sciences

People needed

107

Starts

2012-12-01

Expected to finish

2015-01-01

Last updated by the study team

2016-05-09

Who can join

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

You may qualify if…

• Confirmed diagnosis of CF
• Presence of PA in 2 lower respiratory tract cultures in the 12 months prior to screening
• Forced expiratory volume (FEV)1 ≥ 25 and ≤ 75% predicted
• History of 1 hospitalization or 1 course of IV antibiotics for an acute respiratory exacerbation in the 12 months prior to screening

You may not qualify if…

• Concurrent use of oral, IV or inhaled antibiotics at enrollment
• Concurrent hospitalization at enrollment
• History of local or systemic hypersensitivity to monobactams or aminoglycoside antibiotics or history of aminoglycoside antibiotic associated toxicity

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• University of California - San Diego — La Jolla, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Kaiser Permanente Medical Center — Oakland, California, United States
• National Jewish Health — Denver, Colorado, United States
• Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Central Florida Pulmonary Group — Altamonte Springs, Florida, United States
• University of Florida — Gainesville, Florida, United States
• South Broward Hospital dba Memorial Healthcare System — Hollywood, Florida, United States
• Nemours Children's Clinic - Jacksonville — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Nemours Children's Clinic - Orlando — Orlando, Florida, United States
• Arnold Palmer Hospital for Children — Orlando, Florida, United States
• Nemour's Children's Clinic — Pensacola, Florida, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Emory Cystic Fibrosis Center — Atlanta, Georgia, United States
• Georgia Health — Augusta, Georgia, United States
• St. Lukes Medical Center — Boise, Idaho, United States
• University of Chicago — Chicago, Illinois, United States
• Chicago CF Care Specialists NFP dba Cystic Fibrosis Institure — Glenview, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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