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Ciprofloxacin dispersion for

Phase 3

Non Cystic Fibrosis Bronchiectasis | Small molecule | Respiratory |Grifols, S.A.|Last Updated: Mar 26, 2021

Target and mechanism

ModalitySmall molecule

Also known as Ciprofloxacin dispersion for inhalation

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment582

FDA Designations

No designations recorded

Clinical trial landscape

Ciprofloxacin dispersion for · 2 trials · 1 indication

Phase 3 2
NCT02104245Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)Non Cystic Fibrosis Bronchiectasis
COMPLETED304 Analytics
NCT01515007Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)Non Cystic Fibrosis Bronchiectasis
COMPLETED278 Analytics
PHASE3COMPLETED
Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)
Non Cystic Fibrosis Bronchiectasis
NCT02104245304
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PHASE3COMPLETED
Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)
Non Cystic Fibrosis Bronchiectasis
NCT01515007278
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Study Endpoints

Primary Endpoints

Time to first pulmonary exacerbation (from baseline)
48 weeks
Time to first exacerbation
One Year

Secondary Endpoints

Number of exacerbations
One Year
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ciprofloxacin dispersion for inhalationEXPERIMENTALLiquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin
PlaceboPLACEBO_COMPARATORLiquid formulation of empty liposomes

Interventions

NameTypeDescription
Ciprofloxacin dispersion for inhalationDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites95

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 Exclusion Criteria: * Have a clinical diagnosis of CF * Are pregnant

Countries:United StatesAustraliaCanadaFranceGeorgiaHungaryIsraelItalyNew ZealandPeruPolandRomaniaSerbia and MontenegroSouth KoreaSpainUnited KingdomGermanyIrelandLatviaSouth AfricaTaiwan
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