Status:
COMPLETED
Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex
Lead Sponsor:
Unity Health Toronto
Conditions:
Cystic Fibrosis
Burkholderia Cepacia Infection
Eligibility:
All Genders
6+ years
Phase:
PHASE1
Brief 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 fibros...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02212587
Start Date
September 1 2014
End Date
May 1 2016
Last Update
November 4 2020
Active Locations (2)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
2
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8