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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1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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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 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
15
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Los Angeles, CA
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Miami, Florida 33124
(305) 284-2211
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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1717 South Orange Avenue # 100
Orlando, Florida 32806
(407) 650-7000
Nemours Children's Clinic - Orlando Located near downtown Orlando, Nemours Children’s Clinic, Orlando is a...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
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22 Bramhall St
Portland, Maine 04102
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201 Presidents Circle
Salt Lake City, Utah 84108
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University of Utah Research is a major component in the life of the U benefiting...
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1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
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1 Tampa General Cir
Tampa, Florida 33606
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1600 Rockland Road
Wilmington, Delaware 19803
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
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Albuquerque, New Mexico 87131
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Altamonte Springs, Florida 32701
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
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Atlanta, Georgia 30084
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Augusta, Georgia 30912
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Bedford, New Hampshire 03110
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Boise, Idaho 37012
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Colchester, VT
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Danville, Pennsylvania 17882
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
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Detroit, Michigan 48201
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Farmington Hills, Michigan 48334
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Ft. Worth, Texas 76104
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Grand Rapids, MI
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500 University Dr
Hershey, Pennsylvania 17033
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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Knoxville, Tennessee 37920
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2018 W Clinch Ave
Knoxville, Tennessee 37916
(865) 541-8000
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9500 Gilman Dr
La Jolla, California 92093
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1 Medical Center Dr
Lebanon, New Hampshire 03756
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
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Morgantown, West Virginia 26506
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Morristown, New Jersey 07962
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2200 Children's Way
Nashville, Tennessee 37232
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Emile St
Omaha, Nebraska 68198
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Pensacola, Florida 32504
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
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1919 E Thomas Rd
Phoenix, Arizona 85006
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Richmond, Virginia 23298
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San Antonio, Texas 78212
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501 6th Avenue South
St. Petersburg, Florida 33701
(727) 898-7451
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Syracuse, New York 13210
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Washington DC, District of Columbia 20010
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55 Lake Avenue North
Worcester, Massachusetts 01655
508-334-1000
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