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. 2013 Dec;22(130):476–486. doi: 10.1183/09059180.00001513

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.