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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02104245
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : January 19, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Non Cystic Fibrosis Bronchiectasis Drug: Ciprofloxacin dispersion for inhalation Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2014
Primary Completion Date : August 2016
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ciprofloxacin dispersion for inhalation
Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin
Drug: Ciprofloxacin dispersion for inhalation
Placebo Comparator: Placebo
Liquid formulation of empty liposomes
Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. Time to first pulmonary exacerbation (from baseline) [ Time Frame: 48 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104245


  Show 95 Study Locations
Sponsors and Collaborators
Aradigm Corporation
Grifols Therapeutics Inc.
More Information

Responsible Party: Aradigm Corporation
ClinicalTrials.gov Identifier: NCT02104245     History of Changes
Other Study ID Numbers: ARD-3150-1202
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

Keywords provided by Aradigm Corporation:
Non Cystic Fibrosis Bronchiectasis, Pulmaquin, Ciprofloxacin, Pseudomonas aeruginosa

Additional relevant MeSH terms:
Fibrosis
Bronchiectasis
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors