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Author | Study design | Subjects | Dose used | Outcomes | Main results |
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Chuchalin et al. [7] | Multicenter, RCT | . Age = Adults. Inclusion criteria: chronic P. aeruginosa infection | Tobramycin 300 mg for 24 weeks | Percent change in FEV1, FVC, and FEF25–75%, pulmonary exacerbations, use of parenteral antibiotics, and rate of hospitalizations | Significantly improved FEV1, FVC, and FEF25–75%. The %ofpatientshospitalized as well as the need for parenteral antibiotics was significantly lower |
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Lenoir et al. [8] | RCT | . Age = 6–30 years. Inclusion criteria: chronic P. aeruginosa infection | Tobramycin 300 mg BID for 4 weeks | Percent change in FEV1, FVC, and FEF25–75% | Significantly improved FEV1, FVC, and FEF25–75% |
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MacLusky et al. [9] | RCT | . Age = 7–24 years. Inclusion criteria: chronic P. aeruginosa infection | Tobramycin 80 mg BID for 33 months | Lung function (FEV1 and FVC), clinical scores, and exacerbations | The treatment group showed no change, while the control group had a significant decline in both pulmonary function and clinical status |
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Murphy et al. [10] | Multicenter, RCT | . Age = 6–15 years. Inclusion criteria: CF with mild lung disease | Tobramycin 300 mg BID, alternating 4-weekly cycles for 56 weeks | Lung function, hospitalisation, and antibiotic use | Significant reductions in hospitalizations, antibiotic use, and a trend towards improvement in FEF25–75% |
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Ramsey et al. [11] | Multicenter, Crossover study | . Age = ≥6 years. Inclusion criteria: chronic P. aeruginosa infection and FVC >40% | Tobramycin 600 mg TID for 4 weeks then crossover for two 28-day periods | Lung function (FEV1, FVC, and FEF25–75%), exacerbations of infection and antibiotic use | Increase in the % change in FEV1, FVC, and FEF25–75%. Fewer exacerbations of infection and antibiotic use |
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Ramsey et al. [12] | Multicenter, RCT | . Age = ≥6 years. Inclusion criteria: chronic P. aeruginosa infection, FEV1 ≥25% and ≤75% predicted | Tobramycin 300 mg BID in three on-off cycles for a total of 24 weeks | Lung function (FEV1 and FVC), exacerbations (hospitalization or IV antibiotics) | Increase in the % change in FEV1 and FVC. Fewer hospitalizations and antibiotic use |
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Moss [13] | Multicenter, RCT | . Age = 13–17 years. Inclusion criteria: chronic P. aeruginosa with mild-to-moderate lung disease (FEV1 ≥25% and ≤75% predicted) | Tobramycin 300 mg in three 28-day cycles | Pulmonary function, incidence of hospitalization, and IV antibiotic use | Increase in the % change in FEV1. The average number of hospitalizations and IV antibiotic courses did not increase over time |
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Stelmach et al. [14] | Observational study | . Age = 6–18 years. Inclusion criteria: chronic P. aeruginosa infection with FEV1 ≥25% and ≤75% predicted | Tobramycin 300 mg in two 28-day cycles | Pulmonary function, clinical status over 2-year period | Significant decline in lung function, clinical improvement |
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Galeva et al. [15] | RCT | . Age = 6–21 years. Inclusion criteria: chronic P. aeruginosa infection and FEV1 ≥25% and ≤80% predicted | Tobramycin BID for one treatment cycle (18.5 days on drug, 28 days off drug) | Change in FEV1%, quality of life | Change in FEV1%, quality of life |
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Konstan et al. [16] | RCT | . Age = 6–21 years. Inclusion criteria: chronic P. aeruginosa infection and FEV1 ≥25% and ≤80% predicted | Tobramycin 112 mg BID for a total of three cycles (each cycle, 28 days on and 28 days off drug) | Change in FEV1% | Increase in FEV1% along with decrease in the number of hospitalizations and antibiotic use |
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