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

Unity Health Toronto

Status and phase: Completed; Phase 1

Conditions: Burkholderia Cepacia Infection; Cystic Fibrosis

Treatments: Drug: TOBI

Study type: Interventional

Funder types: Other

Identifiers

NCT02212587

165476 (Other Identifier)

TIPBCC002

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

TOBI Podhaler

Experimental group

Treatment:

Drug: TOBI