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

This study has been completed.
Grifols Therapeutics Inc.
Information provided by (Responsible Party):
Aradigm Corporation Identifier:
First received: January 10, 2012
Last updated: December 2, 2016
Last verified: December 2016
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


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

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 identifier: NCT01515007

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

Responsible Party: Aradigm Corporation Identifier: NCT01515007     History of Changes
Other Study ID Numbers: ARD-3150-1201
Study First Received: January 10, 2012
Last Updated: December 2, 2016

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

Additional relevant MeSH terms:
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases
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 processed this record on September 21, 2017