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.
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.
Study Type
OBSERVATIONAL
Enrollment
409
tobramycin inhalation solution, USP
tobramycin inhalation solution
Absolute change in forced expiratory volume in one second (FEV1) percent predicted from baseline.
Time frame: 1 year
Absolute change from baseline in the number of P. aeruginosa colony forming units in sputum.
Time frame: 1 year
Minimum inhibitory concentration (MIC) of tobramycin and the following antipseudomonal antibacterial drugs (meropenem, imipenem, ceftazidime, aztreonam and ciprofloxacin) for P. aeruginosa sputum isolates in both treatment cohorts.
Time frame: Up to 5 years
Frequency of the following treatment emergent pathogens in sputum: S. aureus (MRSA and MSSA), S. maltophilia, A. xylosoxidans, and Burkholderia spp.in both treatment cohorts.
Time frame: Up to 5 years
Number of pulmonary exacerbations and those leading to hospitalization.
Time frame: 1 year
Proportion of patients experiencing pulmonary exacerbations including those leading to hospitalization.
Time frame: 1 year
Incidence rate of patients with one or more pulmonary exacerbations.
Time frame: 1 year
Incidence rate of pulmonary exacerbations.
Time frame: 1 year
Time to first pulmonary exacerbation.
Time frame: 1 year
Use of additional antipseudomonal antibiotics (overall, IV, oral) to treat pulmonary exacerbations.
Time frame: 1 year
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aztreonam for inhalation solution
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Anchorage, Alaska, United States
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Mortality rate
Time frame: 1 year
Pharmacokinetic properties of TOBI® PODHALER® as measured by sputum specimens collected during the on-treatment cycles.
Time frame: 1 year
Number of respiratory related hospitalizations.
Time frame: 1 year
Duration of stay for respiratory related hospitalizations.
Time frame: 1 year
Number of non-respiratory related hospitalizations.
Time frame: 1 year
Duration of stay for non-respiratory related hospitalizations.
Time frame: 1 year
Relative change in FEV1 % predicted from baseline.
Time frame: 1 year