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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02212587 |
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Date of registration:
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06/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex
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Scientific title:
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Pilot Study of the in Vivo Efficacy of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02212587 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Canada
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Contacts
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Name:
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Valerie Waters, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital of Sick Children |
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Key inclusion & exclusion criteria
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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.
Age minimum:
6 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Burkholderia Cepacia Infection
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Cystic Fibrosis
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Intervention(s)
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Drug: TOBI
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Primary Outcome(s)
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The Change in Sputum Density of BCC in Colony Forming Units (CFUs)/ml From Day 0 to Day 28 of TIP Treatment.
[Time Frame: 0 to 28 days]
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Secondary Outcome(s)
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The Change in Pulmonary Function Tests, Including Forced Expiratory Volume in 1 Second (FEV1), Forced Vital Capacity (FVC) and Maximal Mid-expiratory Flow Rate (FEF25-75), Measured at Day 0 and Day 28 of TIP Treatment.
[Time Frame: 0 to 28 days]
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Secondary ID(s)
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165476
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TIPBCC002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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