A Study to See if AZLI (an Inhaled Antibiotic) is Effective in Treating Adults With Non-CF Bronchiectasis - AIR-BX2



Status:Completed
Conditions:Bronchitis, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:April 2011
End Date:June 2013

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)


The AIR-BX-2 study is for people who have been diagnosed with non-CF bronchiectasis and have
gram-negative airway infection. This is a randomized study, the participants will be
selected by chance (like flipping a coin) to receive one of two treatments (AZLI or
Placebo). This is a double-blind study which means participants and their study doctors will
not know what treatment they are assigned to receive. Participants will receive two 28 day
courses of either AZLI or placebo taken 3 times a day. Each course has a 28 day off-drug
period. Following the blinded courses, all participants will receive AZLI for the third 28
day course.

Based on observed safety and effectiveness of AZLI in the adult CF population, and due to
the similarities in the lung disease for patients with CF and non-CF bronchiectasis, AZLI
represents a potential treatment for people with non-CF bronchiectasis and infection of the
airways.


There will be 10 scheduled study visits. Planned visits include screening prior to
randomization, evaluations at 14-day intervals during the first placebo-controlled course,
and every 28 days subsequently.

Inclusion Criteria:

- Male/Female 18 years or older with non-CF bronchiectasis

- Chronic sputum production on most days

- Positive sputum culture for gram-negative organisms

- Must meet lung function requirements

Exclusion Criteria:

- History of CF

- Hospitalized within 14 days prior to joining the study

- Previous exposure to AZLI for inhalation

- Pregnant, breastfeeding or unwilling to follow contraceptive measures for the study

- Must meet liver and kidney function requirements

- Continuous oxygen use of greater than 2 Liters per minute (supplemental oxygen with
activity and at night is allowed)

- Current treatment for nontuberculous mycobacteria infection or active mycobacterium
tuberculosis infection within 1 year of enrollment

- Other serious medical conditions
We found this trial at
33
sites
Kentuckiana Pulmonary Associates
Louisville, Kentucky 40202
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University of Florida
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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University of Miami Miller School of Medicine
1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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Miami, FL
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Central Florida Pulmonary Group, PA
326 North Mills Avenue
Orlando, Florida 32803
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Orlando, FL
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University of Utah
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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UNC Chapel Hill
CHapel Hill, North Carolina 27599
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University of Chicago Medical Center
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Loess Hills Clinical Research
Council Bluffs, Iowa 51503
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Council Bluffs, IA
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Southeastern Lung Care PC
Decatur, Georgia 30033
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Decatur, GA
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Clinical Trials Connection
Flagstaff, Arizona 86001
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Flagstaff, AZ
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Florence Research Associates
Florence, Alabama 35630
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Florence, AL
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Jamaica Hospital Medical Center
Jamaica, New York 11418
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University of Wisconsin Hospital and Clinics
600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
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Medical College of Wisconsin/ Froedtert Hospital
Milwaukee, Wisconsin 53226
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Milwaukee, WI
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Robert Wood Johnson Medical School
New Brunswick, New Jersey 08901
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New Brunswick, NJ
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Columbia University, NY Presbyterian Hospital
New York, New York 10032
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New York, NY
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Pulmonary Consultants & Primary Care Physicians Medical Group, Inc.
Orange, California 92780
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Orange, CA
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Phoenix Medical Group
Peoria, Arizona 85381
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Peoria, AZ
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University of Pennsylvania Medical Center
Philadelphia, Pennsylvania 19341
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Pulmonary Associates, PA
Phoenix, Arizona 85006
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The Oregon Clinic, PC/Pulmonary Division
Portland, Oregon 97220
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Portland, OR
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Pulmonary & Critical Care Associates of Baltimore
Rosedale, Maryland 21237
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Rosedale, MD
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UC San Diego Medical Center
San Diego, California 92103
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San Diego, CA
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California Pacific Medical Center
45 Castro Street
San Francisco, California 94114
(415) 600-6000
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Sarasota Memorial Hospital - Clinical Research Center
Sarasota, Florida 34239
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Sarasota, FL
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Az Pulmonary Specialists Ltd
Scottsdale, Arizona 85258
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Scottsdale, AZ
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Pasadena Center For Medical Research
St. Petersburg, Florida 33707
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St. Petersburg, FL
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Pulmonary and Allergy Associates
Summit, New Jersey 07901
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Summit, NJ
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Pulmonary Consultants, Pllc
Tacoma, Washington 98405
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Tacoma, WA
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Tampa General Hospital - New Lung Associates
Tampa, Florida 33606
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Tampa, FL
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University of Texas Health Science Center at Tyler
Tyler, Texas 75708
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Tyler, TX
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Georgetown University Hospital
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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Florida Premier Research Institute
Winter Park, Florida 32789
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Winter Park, FL
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