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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/NCT02104245




Registration number
NCT02104245
Ethics application status
Date submitted
28/03/2014
Date registered
4/04/2014
Date last updated
26/03/2021

Titles & IDs
Public title
Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)
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 Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension
Secondary ID [1] 0 0
ARD-3150-1202
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 pulmonary exacerbation (from baseline)
Timepoint [1] 0 0
48 weeks

Eligibility
Key inclusion criteria
- Confirmed diagnosis of non-CF bronchiectasis

- History of P. aeruginosa respiratory infections

- At least two pulmonary exacerbations treated with antibiotics in the previous year
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have a clinical diagnosis of CF

- Are pregnant

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
28/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2016
Sample size
Target
Accrual to date
Final
304
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
- Greenslopes
Recruitment hospital [2] 0 0
- Adelaide
Recruitment hospital [3] 0 0
- Nedlands
Recruitment hospital [4] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
- Greenslopes
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Nedlands
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Connecticut
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United States of America
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Florida
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United States of America
State/province [5] 0 0
Georgia
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United States of America
State/province [6] 0 0
Michigan
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United States of America
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Nebraska
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United States of America
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New Hampshire
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Texas
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United States of America
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Washington
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United States of America
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Wisconsin
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Canada
State/province [19] 0 0
British Columbia
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Canada
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Ontario
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Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Former Serbia and Montenegro
State/province [22] 0 0
Belgrade
Country [23] 0 0
Former Serbia and Montenegro
State/province [23] 0 0
Knez Selo
Country [24] 0 0
Former Serbia and Montenegro
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Kragujevac
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Former Serbia and Montenegro
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Sremska Kamenica
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France
State/province [26] 0 0
Créteil Cedex 01
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France
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Grenoble cedex
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France
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Nice Cedex 1
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France
State/province [29] 0 0
Pessac Cedex
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France
State/province [30] 0 0
Rouen Cedex
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France
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Toulouse cedex 9
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Georgia
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Kutaisi
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Georgia
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Tbilisi
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Hungary
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Budapest
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Hungary
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Nyiregyhaza
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Hungary
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Szekesfehervar
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Hungary
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Torokbalint
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Israel
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Jerusalem
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Tel-Aviv
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Italy
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Avellino
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Italy
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Napoli
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Italy
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Parma
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Italy
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Pisa
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Italy
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San Gerardo
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Italy
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Terni
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Italy
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Trieste
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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New Zealand
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Auckland
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New Zealand
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Waikato
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New Zealand
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Tauranga
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Peru
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Lima
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Poland
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Bialystok
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Poland
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Krakow
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Poland
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Ruda Slaska
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Poland
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Warsaw
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Romania
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Arad
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Romania
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Bucuresti
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Romania
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Cluj-Napoca
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Romania
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Craiova
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Romania
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Iasi
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Spain
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Barcelona
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Spain
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La Coruna
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Spain
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Lleida
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Spain
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Valencia
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Cleveland
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United Kingdom
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Greater Manchester
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United Kingdom
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Cambridge
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United Kingdom
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Colchester
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United Kingdom
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Cottingham
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United Kingdom
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Lancaster
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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North Sheilds
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United Kingdom
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Southampton
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United Kingdom
State/province [80] 0 0
Telford

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-3150-1202, 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 website
https://clinicaltrials.gov/ct2/show/NCT02104245
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
Address 0 0
Country 0 0
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/NCT02104245