Overview

Observational Study in Cystic Fibrosis Patients Using TOBI® Podhaler™ or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs

Status:
Active, not recruiting

Trial end date:
2023-07-31

Target enrollment:

Participant gender:

Summary

This is a multicenter, prospective, two cohort, observational study over a 5-year period in Cystic Fibrosis (CF) patients with chronic Pseudomonas aeruginosa infection.The study will collect data over 1 year on respiratory function, antibacterial effectiveness, and clinical outcomes of treatment with inhaled antipseudomonal antibiotics and data over 5 years on microbiological and safety assessments.

Details

Lead Sponsor:

Mylan Inc.
Novartis Pharmaceuticals

Collaborators:

Cystic Fibrosis Foundation
Cystic Fibrosis Foundation Therapeutics

Treatments:

Anti-Bacterial Agents
Tobramycin