Table 1. Summary of included studies.
First author [ref.] | Study name | Study design | Study location | Intervention | Comparator |
Konstan [15] | EAGER trial | RCT, open-label, non-inferiority trial (n=533) Duration: 24 weeks | 127 centres in 15 countries (including North America, Europe, Australia, Israel and Latin America) | Tobramycin dry powder T-326 Inhaler, 112 mg twice daily; 28 days on followed by 28 days off treatment | Tobramycin solution PARI LC Plus jet nebuliser, 300 mg/5 mL twice daily; 28 days on followed by 28 days off treatment |
Konstan [13] | |||||
Novartis Pharmaceuticals [16] | |||||
European Medicines Agency [18] | |||||
Forest Laboratories Ltd [17] | COLO/DPI/02/06 | RCT, open-label, non-inferiority trial (n=380) Duration: 24 weeks | 66 centres in European Union countries, and Russia and the Ukraine | Colistimethate sodium dry powder Turbospin device, 125 mg twice daily; continuous treatment | Tobramycin solution PARI LC Plus jet nebuliser, 300 mg/5 mL twice daily; 28 days on followed by 28 days off treatment |
European Medicines Agency [1] | |||||
Forest Laboratories Ltd [17] | COLO/DPI/02/05 | RCT, open-label with crossover (n=16) Duration: 8 weeks | 3 centres in the UK | Colistimethate sodium dry powder Turbospin device, 125 mg twice daily; continuous treatment | Colistimethate sodium solution (device not reported), 2 MU twice daily; continuous treatment |
RCT: randomised controlled trial.