Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)



Status:Completed
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:1/21/2018
Start Date:April 2014
End Date:October 2016

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Trial Summary
Trial Overview
Inclusion Criteria

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Subjects With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3)

This study (ARD-3150-1201, ORBIT-3) will evaluate the safety and efficacy of inhaled
Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects
who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history
of pulmonary exacerbations and chronic P. aeruginosa infections.


Inclusion Criteria:

- Verified bronchiectasis diagnosis

- Pseudomonas aeruginosa lung infection

Exclusion Criteria:

- Cystic Fibrosis
We found this trial at
31
sites
Clinical Trial Facility in Chicago Illinois
Chicago, Illinois
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Chicago, IL
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Clinical Trial Facility in Anderson South Carolina
Anderson, South Carolina
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Anderson, SC
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Clinical Trial Facility in Cedar Knolls New Jersey
Cedar Knolls, New Jersey
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Cedar Knolls, NJ
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Clinical Trial Facility in Celebration Florida
Celebration, Florida 34747
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Celebration, FL
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Clinical Trial Facility in Charleston South Carolina
Charleston, South Carolina 29412
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Charleston, SC
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Clinical Trial Facility in Charlotte North Carolina
Charlotte, North Carolina 28207
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Charlotte, NC
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Clinical Trial Facility in Columbia Maryland
Columbia, Maryland 21044
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Columbia, MD
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Clinical Trial Facility in Columbia South Carolina
Columbia, South Carolina
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Columbia, SC
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Clinical Trial Facility in Concord New South Wales
15 Concord Road
Concord, New South Wales 2137
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Concord,
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Clinical Trial Facility in Downey California
Downey, California 90242
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Downey, CA
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Clinical Trial Facility in Falls Church Virginia
Falls Church, Virginia 22042
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Falls Church, VA
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Clinical Trial Facility in Farmington Connecticut
Farmington, Connecticut 06030
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Farmington, CT
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Clinical Trial Facility in Fort Worth Texas
Fort Worth, Texas
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Fort Worth, TX
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Clinical Trial Facility in Huntersville North Carolina
Huntersville, North Carolina 28078
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from
Huntersville, NC
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Clinical Trial Facility in Kailua Hawaii
Kailua, Hawaii 96734
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from
Kailua, HI
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Clinical Trial Facility in Kissimmee Florida
Kissimmee, Florida 34741
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Kissimmee, FL
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Clinical Trial Facility in Lincoln Nebraska
Lincoln, Nebraska 68515
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from
Lincoln, NE
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Clinical Trial Facility in Los Angeles California
Los Angeles, California
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Los Angeles, CA
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Clinical Trial Facility in Miami Florida
Miami, Florida 33136
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Miami, FL
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Clinical Trial Facility in New Hyde Park New York
New Hyde Park, New York 11040
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New Hyde Park, NY
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Clinical Trial Facility in New York New York
New York, New York 10032
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New York, NY
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Clinical Trial Facility in Oklahoma City Oklahoma
Oklahoma City, Oklahoma
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Oklahoma City, OK
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Clinical Trial Facility in Peoria Arizona
Peoria, Arizona 85381
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Peoria, AZ
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Clinical Trial Facility in Phoenix Arizona
Phoenix, Arizona
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Phoenix, AZ
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Clinical Trial Facility in Poway California
Poway, California 92064
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Poway, CA
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Clinical Trial Facility in Rochester Minnesota
Rochester, Minnesota 55905
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Rochester, MN
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Clinical Trial Facility in Royal Oak Michigan
Royal Oak, Michigan 48073
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Royal Oak, MI
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Clinical Trial Facility in Sebring Florida
Sebring, Florida
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Sebring, FL
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Clinical Trial Facility in Syracuse New York
Syracuse, New York 13202
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Syracuse, NY
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Clinical Trial Facility in Tyler Texas
Tyler, Texas 75702
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Tyler, TX
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Clinical Trial Facility in Washington District of Columbia
Washington, District of Columbia
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Washington,
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