A prospective observational study in cystic fibrosis patients with chronic respiratory Pseudomonas aeruginosa infection treated with TOBI® Podhaler™ (tobramycin inhalation powder) or other FDA approved inhaled antipseudomonal antibacterial drugs

Official Title: A prospective observational study in cystic fibrosis patients with chronic respiratory Pseudomonas aeruginosa infection treated with TOBI® Podhaler™ (tobramycin inhalation powder) or other FDA approved inhaled antipseudomonal antibacterial drugs

This study will include CF patients chronically colonized with P. aeruginosa enrolled in the Cystic Fibrosis Foundation (CFF) PortCF registry and using TOBI Podhaler or another FDA-approved inhaled antipseudomonal antibiotic. No therapeutic intervention will be assigned and physicians will use their discretion in choosing a treatment regimen for their patients.

Sputum samples (primarily collected during routine clinical follow-up) from patients able to spontaneously produce sputum will be sent to a central laboratory for analysis.

In addition, this study will include two optional sub-studies for qualifying patients in the first study year - Sputum microbiology sub-study and TOBI Podhaler sputum pharmacokinetics (PK) sub-study.

NCT02449031
McColley, Susanna, MD
Observational
No

Contact Information:

Larissa Rugg

Clinical Research Coordinator

312-227-6865