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

This study has been completed.
Sponsor:
Collaborator:
Grifols Therapeutics Inc.
Information provided by (Responsible Party):
Aradigm Corporation
ClinicalTrials.gov Identifier:
NCT02104245
First received: March 28, 2014
Last updated: December 2, 2016
Last verified: December 2016
  Purpose
This study (ARD-3150-1201, ORBIT-4) will evaluate the safety and efficacy of inhaled Pulmaquin 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 Intervention Phase
Non Cystic Fibrosis Bronchiectasis Drug: Pulmaquin Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Aradigm Corporation:

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

Enrollment: 304
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
Experimental: Pulmaquin
Pulmaquin: Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin
Drug: Pulmaquin
Placebo Comparator: Placebo
Placebo: Liquid formulation of empty liposomes
Drug: Placebo

Detailed Description:

This is a multinational, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Pulmaquin compared to placebo in the management of chronic lung infections with P. aeruginosa in subjects with non-CF bronchiectasis with a history of pulmonary exacerbations.

This study will consist of a Screening Phase, a Double-Blind Phase (6 cycles each consisting of 28-days once daily Pulmaquin or Placebo, and 28 days off treatment) followed by Open-Label Extension (28 days on Pulmaquin).

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02104245

  Show 95 Study Locations
Sponsors and Collaborators
Aradigm Corporation
Grifols Therapeutics Inc.
Investigators
Study Director: Juergen Froehlich, MD Aradigm Corporation
  More Information

Responsible Party: Aradigm Corporation
ClinicalTrials.gov Identifier: NCT02104245     History of Changes
Other Study ID Numbers: ARD-3150-1202
Study First Received: March 28, 2014
Last Updated: December 2, 2016

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

ClinicalTrials.gov processed this record on July 27, 2017