Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Pharmaceutical Solutions; Tobramycin

Criteria

Inclusion Criteria:

• Diagnosis of cystic fibrosis

• Early lower respiratory tract infection with P. aeruginosa,

Exclusion Criteria:

• Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.

• Administration of loop diuretics within 7 days prior to study drug administration.

• Other protocol-defined inclusion/exclusion criteria may apply