NCT02212587

Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex

Pilot Study of the in Vivo Efficacy of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine if tobramycin inhalation powder (TIP) can reduce the amount of Burkholderia Cepacia Complex (BCC) species - type of bacteria, in the sputum of cystic fibrosis patient.

Conditions

• Cystic Fibrosis
• Burkholderia Cepacia Infection

Interventions

Type	Name	Description
DRUG	TOBI	New inhalation devices such as the podhaler can administer tobramycin inhalation powder TIP/TOBI and achieve very high sputum drug levels. TOBI will be administered using the Podhaler

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-08-08
• Last updated: 2020-11-04
• Results posted: 2020-11-04

Locations

2 sites across 1 country: Canada