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

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ClinicalTrials.gov Identifier: NCT01515007
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : January 19, 2018
Sponsor:
Collaborator:
Grifols Therapeutics Inc.
Information provided by (Responsible Party):
Aradigm Corporation

January 10, 2012
January 23, 2012
January 19, 2018
April 2014
August 2016   (Final data collection date for primary outcome measure)
Time to first exacerbation [ Time Frame: One Year ]
Same as current
Complete list of historical versions of study NCT01515007 on ClinicalTrials.gov Archive Site
Number of exacerbations [ Time Frame: One Year ]
Same as current
Not Provided
Not Provided
 
Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non Cystic Fibrosis Bronchiectasis
  • Drug: Ciprofloxacin dispersion for inhalation
    Other Name: Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin
  • Drug: Placebo
    Other Name: Liquid formulation of empty liposomes
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
278
October 2016
August 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Verified bronchiectasis diagnosis
  • Pseudomonas aeruginosa lung infection

Exclusion Criteria:

  • Cystic Fibrosis
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Germany,   Hungary,   Ireland,   Israel,   Italy,   Korea, Republic of,   Latvia,   Poland,   Romania,   South Africa,   Spain,   Taiwan,   United Kingdom,   United States
New Zealand
 
NCT01515007
ARD-3150-1201
No
Not Provided
Not Provided
Aradigm Corporation
Aradigm Corporation
Grifols Therapeutics Inc.
Not Provided
Aradigm Corporation
January 2018

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