Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis "ORBIT-1"
NCT ID: NCT00889967
Last Updated: 2017-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
95 participants
INTERVENTIONAL
2010-02-28
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Ciprofloxacin for Inhalation 100 mg/day by inhalation
Ciprofloxacin for Inhalation
100 mg once daily by inhalation for 28 days
2
Ciprofloxacin for inhalation 150 mg/day by inhalation
Ciprofloxacin for Inhalation
150 mg once daily by inhalation for 28 days
Placebo
Placebo by inhalation
Placebo
Placebo once daily by inhalation for 28 days
Interventions
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Ciprofloxacin for Inhalation
100 mg once daily by inhalation for 28 days
Ciprofloxacin for Inhalation
150 mg once daily by inhalation for 28 days
Placebo
Placebo once daily by inhalation for 28 days
Eligibility Criteria
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Inclusion Criteria
2. Are males or females 18 to 80 year of age, inclusive.
3. Have had a confirmed diagnosis of non-CF bronchiectasis per high resolution computed tomography (HRCT) for at least 4 years.
4. Confirmation of infection with P. aeruginosa at screening
Exclusion Criteria
2. Have an exacerbation during the Screening Phase as defined as requiring treatment with inhaled, oral, or intravenous antibiotics prior to the first dose of study drug.
3. Have a diagnosis of cystic fibrosis..
4. Have had changes in either the treatment regimen or initiation of treatment with any of the following medications within 28 days prior to Visit 1:
* Azithromycin
* Hypertonic saline
* Bronchodilator medications
* Oral corticosteroid.
5. Have received an investigational drug or device within 28 days prior to Visit 1.
6. Have any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patients' treatment, assessment, or compliance with the protocol.
18 Years
80 Years
ALL
No
Sponsors
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Aradigm Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Bruinenberg, MBChB, MBA
Role: STUDY_DIRECTOR
Aradigm Corporation
Locations
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Phoenix, Arizona, United States
Los Angeles, California, United States
Sacramento, California, United States
Torrance, California, United States
Waterbury, Connecticut, United States
Brandon, Florida, United States
Miami, Florida, United States
Council Bluffs, Iowa, United States
Summit, New Jersey, United States
New York, New York, United States
Elizabeth City, North Carolina, United States
Toledo, Ohio, United States
Philadelphia, Pennsylvania, United States
McKinney, Texas, United States
Calgary, Alberta, Canada
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Saint-Jérôme, Quebec, Canada
Berlin, , Germany
Donaustauf, , Germany
Heidelberg, , Germany
Neuwied, , Germany
"Ground Floor, Tower Block, Lisburn Road
Belfast, Britain, United Kingdom
"1st Floor, Nuffield House, B15 2TH
Birmingham, Britain, United Kingdom
"Duckworth Lane,
Bradford, Britain, United Kingdom
"Southmoor Road, M23 9LT
Manchester, Britain, United Kingdom
Newcastle upon Tyne, Freeman Road, High Heaton, United Kingdom
London, High Street Lewisham, United Kingdom
"Bordesley Green East
Birmingham, , United Kingdom
"133 Balornock Road
Glasgow, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
"Stott Lane
Salford, , United Kingdom
"Newcastle Road
Stoke-on-Trent, , United Kingdom
"Northumbria Healthcare
Tyne and Wear, , United Kingdom
Countries
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Other Identifiers
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ARD-3100-0901
Identifier Type: -
Identifier Source: org_study_id
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