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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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
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Oklahoma City, OK
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Anderson, SC
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Cedar Knolls, NJ
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Celebration, FL
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Charleston, South Carolina 29412
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Charleston, SC
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Charlotte, North Carolina 28207
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Charlotte, NC
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Chicago, IL
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Columbia, MD
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Columbia, SC
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15 Concord Road
Concord, New South Wales 2137
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Concord,
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Downey, CA
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Falls Church, VA
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Farmington, CT
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Fort Worth, TX
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Huntersville, North Carolina 28078
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Huntersville, NC
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Kailua, HI
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Kissimmee, FL
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Lincoln, NE
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Los Angeles, CA
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Miami, FL
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New Hyde Park, NY
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New York, NY
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Peoria, AZ
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Phoenix, AZ
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Poway, CA
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Rochester, MN
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Royal Oak, MI
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Sebring, FL
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Syracuse, NY
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Tyler, TX
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Washington,
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