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A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who success...

Update Il y a 4 ans
Reference: EUCTR2009-016734-26

A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1

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Extract

To evaluate the safety profile of tobramycin inhalation powder after modifications in the manufacturing process (TIPnew) for the treatment of infections with P. aeruginosa in patients suffering from cystic fibrosis, over three additional treatment cycles.

Inclusion criteria

  • Pseudomonas aeruginosa infection in cystic fibrosis patients

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