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
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.
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
Inclusion Criteria: 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 Exclusion Criteria: 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.