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 August 2012 by Aradigm Corporation
Sponsor:
Aradigm Corporation
Information provided by (Responsible Party):
Aradigm Corporation
ClinicalTrials.gov Identifier:
NCT01515007
First received: January 10, 2012
Last updated: August 27, 2012
Last verified: August 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 10, 2012 | ||||
| Last Updated Date | August 27, 2012 | ||||
| Start Date ICMJE | December 2012 | ||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Time to first exacerbation [ Time Frame: One Year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01515007 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Number of exacerbations [ Time Frame: One Year ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Phase 3 Study With Dual Release Ciprofloxacin for Inhalation in Non-CF Bronchiectasis | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | The DRCFI treatment will influence the time to first pulmonary exacerbation compared to placebo. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Non Cystic Fibrosis Bronchiectasis | ||||
| Intervention ICMJE | Drug: Ciprofloxacin
once daily for 28 days on and 28 days off for six cycles |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 255 | ||||
| Estimated Completion Date | January 2015 | ||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01515007 | ||||
| Other Study ID Numbers ICMJE | ARD-3150-1201 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Aradigm Corporation | ||||
| Study Sponsor ICMJE | Aradigm Corporation | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Aradigm Corporation | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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