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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
95
100 mg once daily by inhalation for 28 days
150 mg once daily by inhalation for 28 days
Placebo once daily by inhalation for 28 days
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.
Time frame: 28 days
Microbiological efficacy
Time frame: 28 days
Time to, number of, severity of, and time to resolve exacerbations
Time frame: 28 days
Changes in spirometry 4. Quality of life (QOL) 5. Safety and tolerability
Time frame: 28 days
Quality of life (QOL)
Time frame: 28 days
Safety and tolerability
Time frame: 28 days
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Phoenix, Arizona, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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Torrance, California, United States
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Waterbury, Connecticut, United States
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Brandon, Florida, United States
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Miami, Florida, United States
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Council Bluffs, Iowa, United States
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Summit, New Jersey, United States
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New York, New York, United States
...and 27 more locations