- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01515007
Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)
March 23, 2021 updated by: Aradigm Corporation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
278
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Adelaide, Australia
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New South Wales
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Concord, New South Wales, Australia
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Westmead, New South Wales, Australia
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Queensland
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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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South Australia
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Daw Park, South Australia, Australia
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Victoria
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Footscray, Victoria, Australia
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Heidelberg, Victoria, Australia
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Alberta
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Calgary, Alberta, Canada
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British Columbia
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Kelowna, British Columbia, Canada
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Quebec
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Montreal, Quebec, Canada
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Berlin, Germany
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Donaustaff, Germany
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Freiburg, Germany
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Hannover, Germany
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Immenstadt im Allgau, Germany
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Lubeck, Germany
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Munich, Germany
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Schleswig-Holstein
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Borstel, Schleswig-Holstein, 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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Acquaviva delle Fonti, Italy
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Bologna, Italy
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Ferrara, Italy
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Firenze, Italy
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Milano, Italy
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Pisa, Italy
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PV
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Pavia, PV, Italy
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Busan, Korea, Republic of
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Seoul, Korea, Republic of
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Cekule, Latvia
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Daugavpils, Latvia
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Liepaja, Latvia
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Riga, Latvia
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Bialystok, Poland
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Chrzanow, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Bucuresti, Romania
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Constanta, Romania
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Timisoara, Romania
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Amanzimtoti, South Africa
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Cape Town, South Africa
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Krugersdorp, South Africa
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KwaZulu-Natal
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Durban, KwaZulu-Natal, South Africa
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Pietermaritzburg, KwaZulu-Natal, South Africa
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Barcelona, Spain
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Girona, Spain
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Madrid, Spain
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Malaga, Spain
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Islas Baleares
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Palma de Mallorca, Islas Baleares, Spain
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Kaohsiung, Taiwan
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Taichung City, Taiwan
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Taipei City, Taiwan
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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
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Scotland
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Glasgow, Scotland, United Kingdom
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West Midlands
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Birmingham, West Midlands, United Kingdom
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Arizona
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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California
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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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Connecticut
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Farmington, Connecticut, United States
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District of Columbia
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Washington, District of Columbia, United States
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Florida
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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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Hawaii
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Kailua, Hawaii, United States
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Illinois
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Chicago, Illinois, United States
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Maryland
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Columbia, Maryland, United States
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Michigan
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Royal Oak, Michigan, United States
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Minnesota
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Rochester, Minnesota, United States
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Nebraska
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Lincoln, Nebraska, United States
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New Jersey
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Cedar Knolls, New Jersey, United States
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New York
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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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North Carolina
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Charlotte, North Carolina, United States
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Huntersville, North Carolina, United States
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Oklahoma
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Oklahoma City, Oklahoma, United States
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South Carolina
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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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Texas
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Fort Worth, Texas, United States
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Tyler, Texas, United States
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Virginia
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Falls Church, Virginia, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Verified bronchiectasis diagnosis
- Pseudomonas aeruginosa lung infection
Exclusion Criteria:
- Cystic Fibrosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Ciprofloxacin dispersion for inhalation
Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin
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Other Names:
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PLACEBO_COMPARATOR: Placebo
Liquid formulation of empty liposomes
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Time to first exacerbation
Time Frame: One Year
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One Year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Number of exacerbations
Time Frame: One Year
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One Year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Lancet Respir Med. 2019 Jan 25;:
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 31, 2014
Primary Completion (ACTUAL)
August 17, 2016
Study Completion (ACTUAL)
October 1, 2016
Study Registration Dates
First Submitted
January 10, 2012
First Submitted That Met QC Criteria
January 18, 2012
First Posted (ESTIMATE)
January 23, 2012
Study Record Updates
Last Update Posted (ACTUAL)
March 26, 2021
Last Update Submitted That Met QC Criteria
March 23, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Bronchial Diseases
- Fibrosis
- Bronchiectasis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- Ciprofloxacin
Other Study ID Numbers
- ARD-3150-1201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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