Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)
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 Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension
1 other identifier
interventional
304
16 countries
95
Brief Summary
This study (ARD-3150-1202, ORBIT-4) 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 May 2014
95 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2014
CompletedFirst Posted
Study publicly available on registry
April 4, 2014
CompletedStudy Start
First participant enrolled
May 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedMarch 26, 2021
March 1, 2021
2.2 years
March 28, 2014
March 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to first pulmonary exacerbation (from baseline)
48 weeks
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:
- Confirmed diagnosis of non-CF bronchiectasis
- History of P. aeruginosa respiratory infections
- At least two pulmonary exacerbations treated with antibiotics in the previous year
You may not qualify if:
- Have a clinical diagnosis of CF
- Are pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aradigm Corporationlead
- Grifols Therapeutics LLCcollaborator
Study Sites (95)
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Sacramento, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Danbury, Connecticut, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Winter Park, Florida, United States
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Decatur, Georgia, United States
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Duluth, Georgia, United States
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Port Huron, Michigan, United States
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Omaha, Nebraska, United States
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Lebanon, New Hampshire, United States
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Summit, New Jersey, United States
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Albuquerque, New Mexico, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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Columbus, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Rock Hill, South Carolina, United States
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Spartanburg, South Carolina, United States
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Tyler, Texas, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Greenslopes, Queensland, Australia
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Adelaide, South Australia, Australia
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Nedlands, Western Australia, Australia
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Perth, Western Australia, Australia
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Vancouver, British Columbia, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Saint-Jérôme, Quebec, Canada
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Créteil, France
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Grenoble, France
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Nice, France
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Pessac, France
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Rouen, France
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Toulouse, France
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Kutaisi, Georgia
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Tbilisi, Georgia
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Budapest, Hungary
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Nyíregyháza, Hungary
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Székesfehérvár, Hungary
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Törökbálint, Hungary
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Jerusalem, Israel
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Petah Tikva, Israel
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Ramat Gan, Israel
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Tel Aviv, Israel
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Avellino, Italy
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Napoli, Italy
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Parma, Italy
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Pisa, Italy
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San Gerardo, Italy
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Terni, Italy
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Trieste, Italy
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Otahuhu, Auckland, New Zealand
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Hamilton, Waikato Region, New Zealand
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Tauranga, New Zealand
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Jesus Maria, Lima region, Peru
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La Victoria, Lima region, Peru
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Pueblo Libre, Lima region, Peru
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San Juan de Miraflores, Lima region, Peru
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Bialystok, Poland
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Krakow, Poland
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Ruda Śląska, Poland
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Warsaw, Poland
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Arad, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Craiova, Romania
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Iași, Romania
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Belgrade, Serbia and Montenegro
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Knez Selo, Serbia and Montenegro
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Kragujevac, Serbia and Montenegro
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Sremska Kamenica, Serbia and Montenegro
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Suwon, Gyeonggi-do, South Korea
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Daegu, South Korea
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Seoul, South Korea
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A Coruña, Spain
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Barcelona, Spain
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Lleida, Spain
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Valencia, Spain
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Stockton-on-Trees, Cleveland, United Kingdom
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Wigan, Greater Manchester, United Kingdom
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Cambridge, United Kingdom
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Colchester, United Kingdom
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Cottingham, United Kingdom
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Lancaster, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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North Sheilds, United Kingdom
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Southampton, United Kingdom
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Telford, 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
March 28, 2014
First Posted
April 4, 2014
Study Start
May 28, 2014
Primary Completion
August 11, 2016
Study Completion
October 1, 2016
Last Updated
March 26, 2021
Record last verified: 2021-03