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Ciprofloxacin dispersion

Phase 3

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

Ciprofloxacin dispersion 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

Ciprofloxacin dispersion clinical trials

Ciprofloxacin dispersion · 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 BronchiectasisUnlock trial analytics
PHASE3COMPLETED
Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)
Non Cystic Fibrosis BronchiectasisUnlock trial analytics

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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Frequently asked questions about Ciprofloxacin dispersion

What is Ciprofloxacin dispersion for inhalation used for?

Ciprofloxacin dispersion for inhalation is an investigational inhaled antibiotic being developed for non cystic fibrosis bronchiectasis. It is delivered as a dispersion for inhalation to treat this chronic respiratory condition in adults. It is not approved and remains in clinical development.

Who is developing Ciprofloxacin dispersion for inhalation?

Ciprofloxacin dispersion for inhalation is being developed by Grifols, S.A., which trades under the ticker GRFS. Grifols is the sponsor of the Phase 3 clinical program evaluating this inhaled antibiotic in non cystic fibrosis bronchiectasis.

What phase is Ciprofloxacin dispersion for inhalation in?

Ciprofloxacin dispersion for inhalation is in Phase 3 development. Two Phase 3 trials have been completed, and no active trials are currently listed. The drug is investigational and has not been approved for commercial use.

What clinical trials is Ciprofloxacin dispersion for inhalation in?

Ciprofloxacin dispersion for inhalation has been studied in two completed Phase 3 trials: ORBIT-4 (NCT02104245), which enrolled 304 participants, and ORBIT-3 (NCT01515007), which enrolled 278 participants. Both were randomized, double blind, placebo controlled studies in adults with non cystic fibrosis bronchiectasis.