drugset / Trial / NCT01116089

Pharmacokinetic Study of Bramitob® Administered for Inhalation by PARI eFlow® vs PARI LC® PLUS Nebulizer

NCT01116089

Phase 1 Completed 25 enrolled Chiesi Farmaceutici S.p.A.
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to assess pharmacokinetic and safety comparability of Bramitob® when administered for inhalation by using PARI eFlow® rapid electronic nebulizer vs PARI LC® PLUS nebulizer in Cystic Fibrosis Patients infected with Pseudomonas Aeruginosa

Timeline

Start
2010-07
Primary completion
2011-10
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tobramycin Small molecule 300 mg Inhaled

Indications