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

NCT02104245 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2021-03-26

No results posted yet for this study

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.

Conditions

  • Non Cystic Fibrosis Bronchiectasis

Interventions

DRUG

Ciprofloxacin dispersion for inhalation

DRUG

Placebo

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    collaborator INDUSTRY

  • Aradigm Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-28
Primary Completion
2016-08-11
Completion
2016-10-31

Countries

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

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02104245 on ClinicalTrials.gov