Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)
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)
1 other identifier
interventional
278
16 countries
109
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2014
Typical duration for phase_3
109 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2012
CompletedFirst Posted
Study publicly available on registry
January 23, 2012
CompletedStudy Start
First participant enrolled
March 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 17, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedMarch 26, 2021
March 1, 2021
2.4 years
January 10, 2012
March 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to first exacerbation
One Year
Secondary Outcomes (1)
Number of exacerbations
One Year
Study Arms (2)
Ciprofloxacin dispersion for inhalation
EXPERIMENTALLiquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin
Placebo
PLACEBO COMPARATORLiquid formulation of empty liposomes
Interventions
Eligibility Criteria
You may qualify if:
- Verified bronchiectasis diagnosis
- Pseudomonas aeruginosa lung infection
You may not qualify if:
- Cystic Fibrosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aradigm Corporationlead
- Grifols Therapeutics LLCcollaborator
Study Sites (109)
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Downey, California, United States
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Los Angeles, California, United States
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Poway, California, United States
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Farmington, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Celebration, Florida, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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Sebring, Florida, United States
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Kailua, Hawaii, United States
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Chicago, Illinois, United States
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Columbia, Maryland, United States
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Royal Oak, Michigan, United States
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Rochester, Minnesota, United States
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Lincoln, Nebraska, United States
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Cedar Knolls, New Jersey, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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Syracuse, New York, United States
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Charlotte, North Carolina, United States
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Huntersville, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Anderson, South Carolina, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Fort Worth, Texas, United States
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Tyler, Texas, United States
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Falls Church, Virginia, United States
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Concord, New South Wales, Australia
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Westmead, New South Wales, Australia
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Brisbane, Queensland, Australia
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Cairns, Queensland, Australia
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South Brisbane, Queensland, Australia
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Daw Park, South Australia, Australia
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Footscray, Victoria, Australia
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Heidelberg, Victoria, Australia
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Adelaide, Australia
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Calgary, Alberta, Canada
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Kelowna, British Columbia, Canada
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Montreal, Quebec, Canada
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Borstel, Schleswig-Holstein, Germany
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Berlin, Germany
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Donaustaff, Germany
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Freiburg im Breisgau, Germany
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Hanover, Germany
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Immenstadt im Allgäu, Germany
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Lübeck, Germany
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Munich, Germany
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Budapest, Hungary
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Debrecen, Hungary
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Miskolc, Hungary
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Szombathely, Hungary
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Dublin, Ireland
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Galway, Ireland
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Ashkelon, Israel
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Haifa, Israel
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Holon, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Rehovot, Israel
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Tel Aviv, Israel
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Pavia, PV, Italy
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Acquaviva delle Fonti, Italy
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Bologna, Italy
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Ferrara, Italy
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Florence, Italy
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Milan, Italy
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Pisa, Italy
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Cekule, Latvia
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Daugavpils, Latvia
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Liepāja, Latvia
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Riga, Latvia
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Bialystok, Poland
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Chrzanów, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Bucharest, Romania
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Constanța, Romania
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Timișoara, Romania
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Durban, KwaZulu-Natal, South Africa
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Pietermaritzburg, KwaZulu-Natal, South Africa
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Cape Town, South Africa
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eManzimtoti, South Africa
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Krugersdorp, South Africa
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Busan, South Korea
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Seoul, South Korea
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Palma de Mallorca, Balearic Islands, Spain
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Barcelona, Spain
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Girona, Spain
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Madrid, Spain
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Málaga, Spain
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Glasgow, Scotland, United Kingdom
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Birmingham, West Midlands, United Kingdom
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Bradford, United Kingdom
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Dundee, United Kingdom
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Liverpool, United Kingdom
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Llandough, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Nottinghamshire, United Kingdom
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Stoke-on-Trent, United Kingdom
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Tyne and Wear, United Kingdom
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Wolverhampton, United Kingdom
Related Publications (2)
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.
PMID: 32554534DERIVEDHaworth 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.
PMID: 30658914DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2012
First Posted
January 23, 2012
Study Start
March 31, 2014
Primary Completion
August 17, 2016
Study Completion
October 1, 2016
Last Updated
March 26, 2021
Record last verified: 2021-03