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Trial record 1 of 2 for:    Aradigm Corporation | Phase 3
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Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104245
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : March 26, 2021
Sponsor:
Collaborator:
Grifols Therapeutics LLC
Information provided by (Responsible Party):
Savara Inc. ( Aradigm Corporation )

Tracking Information
First Submitted Date  ICMJE March 28, 2014
First Posted Date  ICMJE April 4, 2014
Last Update Posted Date March 26, 2021
Actual Study Start Date  ICMJE May 28, 2014
Actual Primary Completion Date August 11, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2014)
Time to first pulmonary exacerbation (from baseline) [ Time Frame: 48 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)
Official Title  ICMJE 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
Brief Summary This study (ARD-3150-1202, ORBIT-4) 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non Cystic Fibrosis Bronchiectasis
Intervention  ICMJE
  • Drug: Ciprofloxacin dispersion for inhalation
  • Drug: Placebo
Study Arms  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2016)
304
Original Estimated Enrollment  ICMJE
 (submitted: April 2, 2014)
255
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date August 11, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Former Serbia and Montenegro,   France,   Georgia,   Hungary,   Israel,   Italy,   Korea, Republic of,   New Zealand,   Peru,   Poland,   Romania,   Spain,   United Kingdom,   United States
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT02104245
Other Study ID Numbers  ICMJE ARD-3150-1202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Savara Inc. ( Aradigm Corporation )
Study Sponsor  ICMJE Aradigm Corporation
Collaborators  ICMJE Grifols Therapeutics LLC
Investigators  ICMJE Not Provided
PRS Account Savara Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP