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

• ClinicalTrials.gov Identifier: NCT01515007
• Recruitment Status: Completed
• First Posted: January 23, 2012
• Last Update Posted: March 26, 2021
• Sponsor: Aradigm Corporation
• Collaborator: Grifols Therapeutics LLC
• Information provided by (Responsible Party): Savara Inc. ( Aradigm Corporation )

Tracking Information

• First Submitted Date: January 10, 2012
• First Posted Date: January 23, 2012
• Last Update Posted Date: March 26, 2021
• Actual Study Start Date: March 31, 2014
• Actual Primary Completion Date: August 17, 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 18, 2012): Time to first exacerbation [ Time Frame: One Year ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 18, 2012): Number of exacerbations [ Time Frame: One Year ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)
• 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 Subjects With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3)
• Brief Summary: This study (ARD-3150-1201, ORBIT-3) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Non Cystic Fibrosis Bronchiectasis

Intervention

• Drug: Ciprofloxacin dispersion for inhalation
  Other Name: Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin
• Drug: Placebo
  Other Name: Liquid formulation of empty liposomes

Study Arms

• Experimental: Ciprofloxacin dispersion for inhalation
  Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin
  Intervention: Drug: Ciprofloxacin dispersion for inhalation
• Placebo Comparator: Placebo
  Liquid formulation of empty liposomes
  Intervention: Drug: Placebo

Publications *

• Chalmers JD, Cipolla D, Thompson B, Davis AM, O'Donnell A, Tino G, Gonda I, Haworth C, Froehlich J. Changes in respiratory symptoms during 48-week treatment with ARD-3150 (inhaled liposomal ciprofloxacin) in bronchiectasis: results from the ORBIT-3 and -4 studies. Eur Respir J. 2020 Oct 22;56(4):2000110. doi: 10.1183/13993003.00110-2020. Print 2020 Oct.
• Haworth CS, Bilton D, Chalmers JD, Davis AM, Froehlich J, Gonda I, Thompson B, Wanner A, O'Donnell AE. Inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis and chronic lung infection with Pseudomonas aeruginosa (ORBIT-3 and ORBIT-4): two phase 3, randomised controlled trials. Lancet Respir Med. 2019 Mar;7(3):213-226. doi: 10.1016/S2213-2600(18)30427-2. Epub 2019 Jan 15. Erratum In: Lancet Respir Med. 2019 Jan 25;:

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 2, 2016): 278
• Original Estimated Enrollment (submitted: January 18, 2012): 255
• Actual Study Completion Date: October 2016
• Actual Primary Completion Date: August 17, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Verified bronchiectasis diagnosis
• Pseudomonas aeruginosa lung infection

Exclusion Criteria:

• Cystic Fibrosis

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Canada, Germany, Hungary, Ireland, Israel, Italy, Korea, Republic of, Latvia, Poland, Romania, South Africa, Spain, Taiwan, United Kingdom, United States
• Removed Location Countries: New Zealand

Administrative Information

• NCT Number: NCT01515007
• Other Study ID Numbers: ARD-3150-1201
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Savara Inc. ( Aradigm Corporation )
• Original Responsible Party: Same as current
• Current Study Sponsor: Aradigm Corporation
• Original Study Sponsor: Same as current
• Collaborators: Grifols Therapeutics LLC
• Investigators: Not Provided
• PRS Account: Savara Inc.
• Verification Date: March 2021