This is a Phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety, and tolerability of once daily administration of 150 mg of Ciprofloxacin for Inhalation (CFI) in patients with Cystic Fibrosis who have a history of chronic P. aeruginosa lung infection.
This is a Phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety, and tolerability of once daily administration of 150 mg of Ciprofloxacin for Inhalation (CFI) in patients with Cystic Fibrosis who have a history of chronic P. aeruginosa lung infection. Patients will be enrolled and followed in this study for 1 month. This study will consist of a Screening Phase, a Treatment Phase consisting of a 14 days, and a Follow up Phase consisting of a 14 days Off-treatment Period.
Study Type
OBSERVATIONAL
Serum pharmacokinetics
Time frame: Day 1
Microbiological efficacy
Time frame: Day 14
Changes in spirometry
Time frame: Days 1, 7, 14
Quality of life (CFQ-R)
Time frame: Days 1, 7, 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.