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

This study is not yet open for participant recruitment.
Verified March 2014 by Aradigm Corporation
Sponsor:
Information provided by (Responsible Party):
Aradigm Corporation
ClinicalTrials.gov Identifier:
NCT01515007
First received: January 10, 2012
Last updated: March 28, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of exacerbations [ Time Frame: One Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 255
Study Start Date: June 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: July 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Verified bronchiectasis diagnosis
  • Pseudomonas aeruginosa lung infection

Exclusion Criteria:

  • Cystic Fibrosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515007

Contacts
Contact: Juergen Froehlich, MD (617)505-8824 FroehlichJ@aradigm.com

Locations
United Kingdom
Royal Brompton Hospital Not yet recruiting
London, United Kingdom
Sponsors and Collaborators
Aradigm Corporation
  More Information

No publications provided

Responsible Party: Aradigm Corporation
ClinicalTrials.gov Identifier: NCT01515007     History of Changes
Other Study ID Numbers: ARD-3150-1201
Study First Received: January 10, 2012
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Bronchiectasis
Fibrosis
Bronchial Diseases
Respiratory Tract Diseases
Pathologic Processes
Ciprofloxacin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014