Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)
NCT ID: NCT01515007
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
278 participants
INTERVENTIONAL
2014-03-31
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pseudomonas aeruginosa lung infection
Exclusion Criteria
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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Peoria, Arizona, United States
Phoenix, Arizona, United States
Downey, California, United States
Los Angeles, California, United States
Poway, California, United States
Farmington, Connecticut, United States
Washington D.C., District of Columbia, United States
Celebration, Florida, United States
Kissimmee, Florida, United States
Miami, Florida, United States
Sebring, Florida, United States
Kailua, Hawaii, United States
Chicago, Illinois, United States
Columbia, Maryland, United States
Royal Oak, Michigan, United States
Rochester, Minnesota, United States
Lincoln, Nebraska, United States
Cedar Knolls, New Jersey, United States
New Hyde Park, New York, United States
New York, New York, United States
Syracuse, New York, United States
Charlotte, North Carolina, United States
Huntersville, North Carolina, United States
Oklahoma City, Oklahoma, United States
Anderson, South Carolina, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Fort Worth, Texas, United States
Tyler, Texas, United States
Falls Church, Virginia, United States
Concord, New South Wales, Australia
Westmead, New South Wales, Australia
Brisbane, Queensland, Australia
Cairns, Queensland, Australia
South Brisbane, Queensland, Australia
Daw Park, South Australia, Australia
Footscray, Victoria, Australia
Heidelberg, Victoria, Australia
Adelaide, , Australia
Calgary, Alberta, Canada
Kelowna, British Columbia, Canada
Montreal, Quebec, Canada
Borstel, Schleswig-Holstein, Germany
Berlin, , Germany
Donaustaff, , Germany
Freiburg im Breisgau, , Germany
Hanover, , Germany
Immenstadt im Allgäu, , Germany
Lübeck, , Germany
Munich, , Germany
Budapest, , Hungary
Debrecen, , Hungary
Miskolc, , Hungary
Szombathely, , Hungary
Dublin, , Ireland
Galway, , Ireland
Ashkelon, , Israel
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Pavia, PV, Italy
Acquaviva delle Fonti, , Italy
Bologna, , Italy
Ferrara, , Italy
Florence, , Italy
Milan, , Italy
Pisa, , Italy
Cekule, , Latvia
Daugavpils, , Latvia
Liepāja, , Latvia
Riga, , Latvia
Bialystok, , Poland
Chrzanów, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Bucharest, , Romania
Constanța, , Romania
Timișoara, , Romania
Durban, KwaZulu-Natal, South Africa
Pietermaritzburg, KwaZulu-Natal, South Africa
Cape Town, , South Africa
eManzimtoti, , South Africa
Krugersdorp, , South Africa
Busan, , South Korea
Seoul, , South Korea
Palma de Mallorca, Balearic Islands, Spain
Barcelona, , Spain
Girona, , Spain
Madrid, , Spain
Málaga, , Spain
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Glasgow, Scotland, United Kingdom
Birmingham, West Midlands, United Kingdom
Bradford, , United Kingdom
Dundee, , United Kingdom
Liverpool, , United Kingdom
Llandough, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Nottinghamshire, , United Kingdom
Stoke-on-Trent, , United Kingdom
Tyne and Wear, , United Kingdom
Wolverhampton, , 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-3150-1201
Identifier Type: -
Identifier Source: org_study_id
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