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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Aradigm Corporation
Sponsor:
Collaborator:
Grifols Therapeutics Inc.
Information provided by (Responsible Party):
Aradigm Corporation
ClinicalTrials.gov Identifier:
NCT01515007
First received: January 10, 2012
Last updated: November 20, 2014
Last verified: November 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: April 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
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: NCT01515007

Contacts
Contact: Juergen Froehlich, MD FroehlichJ@aradigm.com
Contact: Debbie Pieretti PierettiD@aradigm.com

  Show 92 Study Locations
Sponsors and Collaborators
Aradigm Corporation
Grifols Therapeutics Inc.
  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: November 20, 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
Pathologic Processes
Respiratory Tract Diseases
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 24, 2014