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

• Status: Terminated
• Trial end date: 2017-04-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Tobramycin

Criteria

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