Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis "ORBIT-1"
An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared With Placebo for Inhalation in the Management of Pseudomonas Aeruginosa in Patients With Non Cystic Fibrosis Bronchiectasis
1 other identifier
interventional
95
4 countries
37
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of Ciprofloxacin for Inhalation in the treatment of patients with non-cystic fibrosis (CF) bronchiectasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2010
Shorter than P25 for phase_2
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2009
CompletedFirst Posted
Study publicly available on registry
April 29, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJanuary 25, 2017
August 1, 2012
1.2 years
April 27, 2009
January 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary efficacy endpoint is defined as the mean change in P. aeruginosa density in sputum (log10) CFU/gram of sputum from Baseline to Day 28.
28 days
Secondary Outcomes (5)
Microbiological efficacy
28 days
Time to, number of, severity of, and time to resolve exacerbations
28 days
Changes in spirometry 4. Quality of life (QOL) 5. Safety and tolerability
28 days
Quality of life (QOL)
28 days
Safety and tolerability
28 days
Study Arms (3)
1
EXPERIMENTALCiprofloxacin for Inhalation 100 mg/day by inhalation
2
EXPERIMENTALCiprofloxacin for inhalation 150 mg/day by inhalation
Placebo
PLACEBO COMPARATORPlacebo by inhalation
Interventions
Eligibility Criteria
You may qualify if:
- Are willing and able to provide written informed consent.
- Are males or females 18 to 80 year of age, inclusive.
- Have had a confirmed diagnosis of non-CF bronchiectasis per high resolution computed tomography (HRCT) for at least 4 years.
- Confirmation of infection with P. aeruginosa at screening
You may not qualify if:
- Have a known local or systemic hypersensitivity to fluoroquinolone or quinolone antibiotics.
- 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.
- Have a diagnosis of cystic fibrosis..
- 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.
- Have received an investigational drug or device within 28 days prior to Visit 1.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Unknown Facility
Phoenix, Arizona, 85006, United States
Unknown Facility
Los Angeles, California, 90048, United States
Unknown Facility
Sacramento, California, 95819, United States
Unknown Facility
Torrance, California, 90505, United States
Unknown Facility
Waterbury, Connecticut, 06708, United States
Unknown Facility
Brandon, Florida, 33511, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Council Bluffs, Iowa, 51503, United States
Unknown Facility
Summit, New Jersey, 07901, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
Elizabeth City, North Carolina, 27909, United States
Unknown Facility
Toledo, Ohio, 43614, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
McKinney, Texas, 75069, United States
Unknown Facility
Calgary, Alberta, T2N 1L9, Canada
Unknown Facility
Kelowna, British Columbia, V1Y 1E4, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 1M9, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 4E1, Canada
Unknown Facility
Ottawa, Ontario, K1Y 4E9, Canada
Unknown Facility
Montreal, Quebec, H2W 1T8, Canada
Unknown Facility
Saint-Jérôme, Quebec, J7Z 5T3, Canada
Unknown Facility
Berlin, 13353, Germany
Unknown Facility
Donaustauf, 93093, Germany
Unknown Facility
Heidelberg, 69126, Germany
Unknown Facility
Neuwied, 56564, Germany
"Ground Floor, Tower Block, Lisburn Road
Belfast, Britain, BT9 7AB, United Kingdom
"1st Floor, Nuffield House, B15 2TH
Birmingham, Britain, United Kingdom
"Duckworth Lane,
Bradford, Britain, BD9 6RJ, United Kingdom
"Southmoor Road, M23 9LT
Manchester, Britain, United Kingdom
Unknown Facility
Newcastle upon Tyne, Freeman Road, High Heaton, NE7 7DN, United Kingdom
Unknown Facility
London, High Street Lewisham, SE13 6LH, United Kingdom
"Bordesley Green East
Birmingham, B9 5SS, United Kingdom
"133 Balornock Road
Glasgow, G21 3UW, United Kingdom
Royal Brompton Hospital
London, SW3 6NP, United Kingdom
"Stott Lane
Salford, M6 8HD, United Kingdom
"Newcastle Road
Stoke-on-Trent, ST4 6QG, United Kingdom
"Northumbria Healthcare
Tyne and Wear, NE29 8NH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paul Bruinenberg, MBChB, MBA
Aradigm Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2009
First Posted
April 29, 2009
Study Start
February 1, 2010
Primary Completion
April 1, 2011
Study Completion
June 1, 2011
Last Updated
January 25, 2017
Record last verified: 2012-08