Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02104245

Enrollment

304

Registered

2014-04-04

Start date

2014-05-28

Completion date

2016-10-31

Last updated

2021-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Cystic Fibrosis Bronchiectasis

Keywords

Non Cystic Fibrosis Bronchiectasis, Pulmaquin, Ciprofloxacin, Pseudomonas aeruginosa

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.

Interventions

DRUGCiprofloxacin dispersion for inhalation

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to first pulmonary exacerbation (from baseline)	48 weeks

Countries

Australia, Canada, France, Georgia, Hungary, Israel, Italy, New Zealand, Peru, Poland, Romania, Serbia and Montenegro, South Korea, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026