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.
Age range
6 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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