Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex
NCT ID: NCT02212587
Last Updated: 2020-11-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2014-09-30
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TOBI Podhaler
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Years
ALL
No
Sponsors
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Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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Valerie Waters, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital of Sick Children
Locations
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St. Michael's Hospital
Toronto, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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References
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Waters V, Yau Y, Beaudoin T, Wettlaufer J, Tom SK, McDonald N, Rizvi L, Klingel M, Ratjen F, Tullis E. Pilot trial of tobramycin inhalation powder in cystic fibrosis patients with chronic Burkholderia cepacia complex infection. J Cyst Fibros. 2017 Jul;16(4):492-495. doi: 10.1016/j.jcf.2017.02.008. Epub 2017 Mar 3.
Other Identifiers
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165476
Identifier Type: OTHER
Identifier Source: secondary_id
TIPBCC002
Identifier Type: -
Identifier Source: org_study_id