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

This study has been completed.
Sponsor:
Collaborator:
Grifols Therapeutics Inc.
Information provided by (Responsible Party):
Aradigm Corporation
ClinicalTrials.gov Identifier:
NCT01515007
First received: January 10, 2012
Last updated: December 2, 2016
Last verified: December 2016
January 10, 2012
December 2, 2016
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 Dual Release Ciprofloxacin for Inhalation in Non-CF Bronchiectasis
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
The DRCFI treatment will influence the time to first pulmonary exacerbation compared to placebo.
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
once daily for 28 days on and 28 days off for six cycles
  • Active Comparator: DRCFI
    Dual Release Ciprofloxacin for Inhalation
    Intervention: Drug: Ciprofloxacin
  • Placebo Comparator: PLI
    Placebo Liposomes for Inhalation
    Intervention: Drug: Ciprofloxacin
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
December 2016

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