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A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Mod...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-002318-22

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew)

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Extrait

To evaluate the efficacy of tobramycin inhalation powder after modifications in the manufacturing process (TIPnew) for the treatment of infections with P. aeruginosa in cystic fibrosis subjects, assessed by relative change from baseline FEV1 percent predicted to day 29, compared to placebo.

Critère d'inclusion

  • Pseudomonas aeruginosa infection in cystic fibrosis patients

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