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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01515007
Registration number
NCT01515007
Ethics application status
Date submitted
10/01/2012
Date registered
23/01/2012
Date last updated
26/03/2021
Titles & IDs
Public title
Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)
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Scientific title
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)
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Secondary ID [1]
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ARD-3150-1201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non Cystic Fibrosis Bronchiectasis
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Ciprofloxacin dispersion for inhalation - Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin
Placebo comparator: Placebo - Liquid formulation of empty liposomes
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to first exacerbation
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Assessment method [1]
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Timepoint [1]
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One Year
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Secondary outcome [1]
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Number of exacerbations
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Assessment method [1]
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Timepoint [1]
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One Year
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Eligibility
Key inclusion criteria
* Verified bronchiectasis diagnosis
* Pseudomonas aeruginosa lung infection
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Cystic Fibrosis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/03/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2016
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Sample size
Target
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Accrual to date
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Final
278
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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- Concord
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- Westmead
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- Brisbane
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- Cairns
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- South Brisbane
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- Daw Park
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- Footscray
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- Heidelberg
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- Adelaide
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- Concord
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- Westmead
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- Brisbane
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- Daw Park
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- Heidelberg
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- Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Aradigm Corporation
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Address
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Other collaborator category [1]
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Name [1]
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Grifols Therapeutics LLC
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01515007
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Trial related presentations / 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 Mar;7(3):e12. doi: 10.1016/S2213-2600(19)30026-8.
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Public notes
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Contacts
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01515007
Download to PDF