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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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)
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)
Secondary ID [1] 0 0
ARD-3150-1201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Cystic Fibrosis Bronchiectasis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ciprofloxacin dispersion for inhalation
Treatment: Drugs - Placebo

Experimental: Ciprofloxacin dispersion for inhalation - Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin

Placebo Comparator: Placebo - Liquid formulation of empty liposomes


Treatment: Drugs: Ciprofloxacin dispersion for inhalation


Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first exacerbation
Timepoint [1] 0 0
One Year
Secondary outcome [1] 0 0
Number of exacerbations
Timepoint [1] 0 0
One Year

Eligibility
Key inclusion criteria
- Verified bronchiectasis diagnosis

- Pseudomonas aeruginosa lung infection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Cystic Fibrosis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2016
Sample size
Target
Accrual to date
Final
278
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Concord
Recruitment hospital [2] 0 0
- Westmead
Recruitment hospital [3] 0 0
- Brisbane
Recruitment hospital [4] 0 0
- Cairns
Recruitment hospital [5] 0 0
- South Brisbane
Recruitment hospital [6] 0 0
- Daw Park
Recruitment hospital [7] 0 0
- Footscray
Recruitment hospital [8] 0 0
- Heidelberg
Recruitment hospital [9] 0 0
- Adelaide
Recruitment postcode(s) [1] 0 0
- Concord
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- Westmead
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Cairns
Recruitment postcode(s) [5] 0 0
- South Brisbane
Recruitment postcode(s) [6] 0 0
- Daw Park
Recruitment postcode(s) [7] 0 0
- Footscray
Recruitment postcode(s) [8] 0 0
- Heidelberg
Recruitment postcode(s) [9] 0 0
- Adelaide
Recruitment outside Australia
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Arizona
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California
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Connecticut
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District of Columbia
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Texas
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Canada
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British Columbia
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Quebec
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Germany
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Schleswig-Holstein
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Germany
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Berlin
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Freiburg
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Hannover
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Germany
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Immenstadt im Allgau
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Germany
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Lubeck
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Germany
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Munich
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Budapest
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Debrecen
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Miskolc
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PV
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Italy
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Malaga
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Kaohsiung
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Taipei City
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Scotland
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West Midlands
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Bradford
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Dundee
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Liverpool
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Llandough
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Manchester
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Newcastle upon Tyne
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Nottinghamshire
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Stoke-on-Trent
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United Kingdom
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Tyne And Wear
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United Kingdom
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Aradigm Corporation
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Grifols Therapeutics LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01515007
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01515007