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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01515007
First Posted: January 23, 2012
Last Update Posted: December 6, 2016
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.
Collaborator:
Grifols Therapeutics Inc.
Information provided by (Responsible Party):
Aradigm Corporation
  Purpose
The DRCFI treatment will influence the time to first pulmonary exacerbation compared to placebo.

Condition Intervention Phase
Non Cystic Fibrosis Bronchiectasis Drug: Ciprofloxacin Phase 3

Study Type: Interventional
Study Design: 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 Time to First Pulmonary Exacerbation, Safety and Efficacy of ARD-3150 (Dual Release Ciprofloxacin for Inhalation-DRCFI) Compared With Placebo in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Patients With Non-Cystic Fibrosis Bronchiectasis

Resource links provided by NLM:


Further study details as provided by Aradigm Corporation:

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

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

Enrollment: 278
Study Start Date: April 2014
Study Completion Date: October 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DRCFI
Dual Release Ciprofloxacin for Inhalation
Drug: Ciprofloxacin
once daily for 28 days on and 28 days off for six cycles
Placebo Comparator: PLI
Placebo Liposomes for Inhalation
Drug: Ciprofloxacin
once daily for 28 days on and 28 days off for six cycles

  Eligibility

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:

  • Verified bronchiectasis diagnosis
  • Pseudomonas aeruginosa lung infection

Exclusion Criteria:

  • Cystic Fibrosis
  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): NCT01515007


  Show 109 Study Locations
Sponsors and Collaborators
Aradigm Corporation
Grifols Therapeutics Inc.
  More Information

Responsible Party: Aradigm Corporation
ClinicalTrials.gov Identifier: NCT01515007     History of Changes
Other Study ID Numbers: ARD-3150-1201
First Submitted: January 10, 2012
First Posted: January 23, 2012
Last Update Posted: December 6, 2016
Last Verified: December 2016

Keywords provided by Aradigm Corporation:
Bronchiectasis, non-CF, Ciprofloxacin, Liposome

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