NCT02449031

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 409 (actual)
• Sponsor: Mylan Inc. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Pseudomonas Aeruginosa in Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	TOBI® PODHALER®
DRUG	TOBI®	tobramycin inhalation solution, USP
DRUG	Bethkis®	tobramycin inhalation solution
DRUG	Cayston®	aztreonam for inhalation solution

Timeline

• Start date: 2015-05-05
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2015-05-20
• Last updated: 2022-03-22

Locations

47 sites across 1 country: United States