NCT01519661

Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis

A Single Arm, Open-label, Multicenter, Phase IV Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.

Conditions

• Pulmonary Infections
• Pseudomonas Aeruginosa in Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	TBM100	Tobramycin inhalation powder was assigned as four capsules at 28mg dosage strength. It was inhaled b.i.d in the morning and in the evening via the T-326 Inhaler.

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-01-27
• Last updated: 2015-02-10
• Results posted: 2015-02-10

Locations

49 sites across 10 countries: United States, Argentina, Australia, Canada, France, Germany, Hungary, Italy, Mexico, Spain