Evaluation of Lung Clearance Index in Cystic Fibrosis (CF) Patients, Infected With P.Aeruginosa

An 8 Week Open-label Interventional Multicenter Study to Evaluate the Lung Clearance Index as Endpoint for Clinical Trials in Cystic Fibrosis Patients ≥ 6 Years of Age, Chronically Infected With Pseudomonas Aeruginosa

The purpose of the study was to evaluate lung clearance index (LCI) by a standardized procedure in a well characterized study setting and to assess feasibility of LCI as a more sensitive method than forced expiratory volume at 1 second (FEV1) to measure effectiveness of antibiotic therapy in patients with CF aged 6 years and older with mild to moderate lung disease.

This study was terminated prematurely. The reason for trial termination was challenge with enrollment and patient recruitment. A significant decrease in the eligible patient population had been identified as main driver.

Inclusion Criteria:

• Confirmed diagnosis of CF
• Patients with elevated LCI of ≥ 7.5 at screening
• Patients with FEV1 of ≥ 50% predicted at screening
• Use of inhaled Tobramycin in a 28 days on / off regimen in the past 3 months before screening
• chronic lung Infection with Pseudomonas aeruginosa

Exclusion Criteria:

• Patients who are regularly receiving more than one class of inhaled anti-pseudomonal antibiotic
• Patients who have used oral or intravenous anti-pseudomonal antibiotics within 28 days prior to on-phase of study drug
• Pregnant or nursing (lactating) women
• Change in dose, formulation or strength of the study drug in the past treatment cycle before screening
• History of hearing loss or chronic tinnitus
• Infection with Burkholderia cenocepacia complex

Other protocol-defined inclusion/exclusion criteria may apply