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.
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Absolute change in forced expiratory volume in one second (FEV1) percent predicted from baseline.
Timeframe: 1 year
Absolute change from baseline in the number of P. aeruginosa colony forming units in sputum.
Timeframe: 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.
Timeframe: 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.
Timeframe: Up to 5 years
Number of pulmonary exacerbations and those leading to hospitalization.
Timeframe: 1 year
Proportion of patients experiencing pulmonary exacerbations including those leading to hospitalization.
Timeframe: 1 year
Incidence rate of patients with one or more pulmonary exacerbations.
Timeframe: 1 year
Incidence rate of pulmonary exacerbations.
Timeframe: 1 year
Time to first pulmonary exacerbation.
Timeframe: 1 year
Use of additional antipseudomonal antibiotics (overall, IV, oral) to treat pulmonary exacerbations.
Timeframe: 1 year
Mortality rate
Timeframe: 1 year
Pharmacokinetic properties of TOBI® PODHALER® as measured by sputum specimens collected during the on-treatment cycles.
Timeframe: 1 year
Number of respiratory related hospitalizations.
Timeframe: 1 year
Duration of stay for respiratory related hospitalizations.
Timeframe: 1 year
Number of non-respiratory related hospitalizations.
Timeframe: 1 year
Duration of stay for non-respiratory related hospitalizations.
Timeframe: 1 year