Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)
NCT ID: NCT02104245
Last Updated: 2021-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
304 participants
INTERVENTIONAL
2014-05-28
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ciprofloxacin dispersion for inhalation
Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin
Ciprofloxacin dispersion for inhalation
Placebo
Liquid formulation of empty liposomes
Placebo
Interventions
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Ciprofloxacin dispersion for inhalation
Placebo
Eligibility Criteria
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Inclusion Criteria
* History of P. aeruginosa respiratory infections
* At least two pulmonary exacerbations treated with antibiotics in the previous year
Exclusion Criteria
* Are pregnant
18 Years
ALL
No
Sponsors
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Grifols Therapeutics LLC
INDUSTRY
Aradigm Corporation
INDUSTRY
Responsible Party
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Locations
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Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Sacramento, California, United States
San Diego, California, United States
Torrance, California, United States
Danbury, Connecticut, United States
Miami, Florida, United States
Orlando, Florida, United States
Winter Park, Florida, United States
Decatur, Georgia, United States
Duluth, Georgia, United States
Port Huron, Michigan, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
Summit, New Jersey, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Rock Hill, South Carolina, United States
Spartanburg, South Carolina, United States
Tyler, Texas, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Greenslopes, Queensland, Australia
Adelaide, South Australia, Australia
Nedlands, Western Australia, Australia
Perth, Western Australia, Australia
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Saint-Jérôme, Quebec, Canada
Créteil, , France
Grenoble, , France
Nice, , France
Pessac, , France
Rouen, , France
Toulouse, , France
Kutaisi, , Georgia
Tbilisi, , Georgia
Budapest, , Hungary
Nyíregyháza, , Hungary
Székesfehérvár, , Hungary
Törökbálint, , Hungary
Jerusalem, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
Avellino, , Italy
Napoli, , Italy
Parma, , Italy
Pisa, , Italy
San Gerardo, , Italy
Terni, , Italy
Trieste, , Italy
Otahuhu, Auckland, New Zealand
Hamilton, Waikato Region, New Zealand
Tauranga, , New Zealand
Jesus Maria, Lima region, Peru
La Victoria, Lima region, Peru
Pueblo Libre, Lima region, Peru
San Juan de Miraflores, Lima region, Peru
Bialystok, , Poland
Krakow, , Poland
Ruda Śląska, , Poland
Warsaw, , Poland
Arad, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Craiova, , Romania
Iași, , Romania
Belgrade, , Serbia and Montenegro
Knez Selo, , Serbia and Montenegro
Kragujevac, , Serbia and Montenegro
Sremska Kamenica, , Serbia and Montenegro
Suwon, Gyeonggi-do, South Korea
Daegu, , South Korea
Seoul, , South Korea
A Coruña, , Spain
Barcelona, , Spain
Lleida, , Spain
Valencia, , Spain
Stockton-on-Trees, Cleveland, United Kingdom
Wigan, Greater Manchester, United Kingdom
Cambridge, , United Kingdom
Colchester, , United Kingdom
Cottingham, , United Kingdom
Lancaster, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
North Sheilds, , United Kingdom
Southampton, , United Kingdom
Telford, , United Kingdom
Countries
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References
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Chalmers JD, Cipolla D, Thompson B, Davis AM, O'Donnell A, Tino G, Gonda I, Haworth C, Froehlich J. Changes in respiratory symptoms during 48-week treatment with ARD-3150 (inhaled liposomal ciprofloxacin) in bronchiectasis: results from the ORBIT-3 and -4 studies. Eur Respir J. 2020 Oct 22;56(4):2000110. doi: 10.1183/13993003.00110-2020. Print 2020 Oct.
Haworth CS, Bilton D, Chalmers JD, Davis AM, Froehlich J, Gonda I, Thompson B, Wanner A, O'Donnell AE. Inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis and chronic lung infection with Pseudomonas aeruginosa (ORBIT-3 and ORBIT-4): two phase 3, randomised controlled trials. Lancet Respir Med. 2019 Mar;7(3):213-226. doi: 10.1016/S2213-2600(18)30427-2. Epub 2019 Jan 15.
Other Identifiers
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ARD-3150-1202
Identifier Type: -
Identifier Source: org_study_id
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