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

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Michael's Hospital, Toronto; Unity Health Toronto
• Treatments: Tobramycin

Criteria

Inclusion Criteria:

• Age 6 years or older

• Diagnosis of CF based on the following: sweat chloride>60 mEq/L or genotype with 2 identifiable mutations consistent with CF; and one or more clinical features consistent with CF.

• Chronically infected with a Burkholderia cepacia complex species (>50% of respiratory specimens positive in the 24 months prior to screening).

• Able to produce sputum (expectorated or induced).

• Able to reproducibly perform pulmonary function testing.

• Written informed consent provided.

Exclusion Criteria:

• Post lung transplantation.

• Pregnancy.

• Acute exacerbation requiring IV or oral antibiotics within 14 days

• Patients currently receiving inhaled tobramycin/TOBI

• A septic or clinically unstable patient, as determined by the investigator.