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

This study is not yet open for participant recruitment.
Verified April 2014 by Aradigm Corporation
Sponsor:
Collaborator:
Grifols Therapeutics Inc.
Information provided by (Responsible Party):
Aradigm Corporation
ClinicalTrials.gov Identifier:
NCT01515007
First received: January 10, 2012
Last updated: April 17, 2014
Last verified: April 2014

January 10, 2012
April 17, 2014
June 2014
July 2016   (final data collection date for primary outcome measure)
Time to first exacerbation [ Time Frame: One Year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01515007 on ClinicalTrials.gov Archive Site
Number of exacerbations [ Time Frame: One Year ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Not yet recruiting
255
September 2016
July 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Verified bronchiectasis diagnosis
  • Pseudomonas aeruginosa lung infection

Exclusion Criteria:

  • Cystic Fibrosis
Both
18 Years and older
No
Contact: Juergen Froehlich, MD (617)505-8824 FroehlichJ@aradigm.com
United Kingdom
 
NCT01515007
ARD-3150-1201
No
Aradigm Corporation
Aradigm Corporation
Grifols Therapeutics Inc.
Not Provided
Aradigm Corporation
April 2014

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