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



Status:Completed
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:6 - Any
Updated:5/5/2014
Start Date:November 2012
End Date:June 2015
Contact:Sheila Leitzinger
Email:sheila.leitzinger@gilead.com
Phone:206 256-4904

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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas Aeruginosa Infection in Subjects With Cystic Fibrosis

This study is to investigate whether using a continuous alternating therapy (CAT) regimen of
2 antibiotics of different classes and with different mechanisms of action may provide the
clinical benefits of reducing acute pulmonary exacerbations, maintaining lung function, and
controlling respiratory symptoms for cystic fibrosis (CF) patients while minimizing the risk
of emergence of antibiotic-resistant Pseudomonas aeruginosa (PA) strains.

After screening, eligible participants will be enrolled into the study and begin a 28-day
run in period of tobramycin inhalation solution (TIS) twice daily. After the run-in,
participants will return to the clinic and be randomized to either the Aztreonam for
Inhalation Solution (AZLI) arm or the placebo arm. The AZLI arm has 3 cycles of AZLI three
times daily for 28 days alternating with TIS twice daily for 28 days. The placebo arm has 3
cycles of placebo three times daily for 28 days alternating with 3 cycles of TIS twice daily
for 28 days. Participants will return to the clinic for evaluation after each cycle of
antibiotics for evaluation. There will be 9 scheduled study visits per participant.


Inclusion Criteria:

- Confirmed diagnosis of CF

- Presence of PA in 2 lower respiratory tract cultures in the 12 months prior to
screening

- FEV1 ≥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

Exclusion Criteria:

- 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
We found this trial at
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425 University Blvd.
Indianapolis, Indiana 46202
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1 Perkins Square
Akron, Ohio 44308
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1720 2nd Ave S
Birmingham, Alabama 35233
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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Gainesville, Florida 32610
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2500 N State St
Jackson, Mississippi 39216
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807 Childrens Way
Jacksonville, Florida 32207
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4650 Sunset Blvd
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Miami, Florida 33124
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601 Children's Lane
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1717 South Orange Avenue # 100
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201 Presidents Circle
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500 S State St
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171 Ashley Avenue
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