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

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ClinicalTrials.gov Identifier: NCT01515007
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : March 26, 2021
Sponsor:
Collaborator:
Grifols Therapeutics LLC
Information provided by (Responsible Party):
Savara Inc. ( Aradigm Corporation )

Study Description
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Brief Summary:
This study (ARD-3150-1201, ORBIT-3) 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 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 Subjects With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3)
Actual Study Start Date : March 31, 2014
Actual Primary Completion Date : August 17, 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Time to first exacerbation [ Time Frame: One Year ]

Secondary Outcome Measures :
  1. Number of exacerbations [ Time Frame: One Year ]

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

Inclusion Criteria:

  • Verified bronchiectasis diagnosis
  • Pseudomonas aeruginosa lung infection

Exclusion Criteria:

  • Cystic Fibrosis
Contacts and Locations
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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): NCT01515007


Locations
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Sponsors and Collaborators
Aradigm Corporation
Grifols Therapeutics LLC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Aradigm Corporation
ClinicalTrials.gov Identifier: NCT01515007    
Other Study ID Numbers: ARD-3150-1201
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021
Keywords provided by Savara Inc. ( Aradigm Corporation ):
Bronchiectasis, non-CF, Ciprofloxacin, Liposome
Additional relevant MeSH terms:
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Bronchiectasis
Fibrosis
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