Phase 1
N=10
Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex
Cystic Fibrosis · Burkholderia Cepacia Infection
Bottom Line
View on ClinicalTrials.gov: NCT02212587 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: The Change in Sputum Density of BCC in Colony Forming Units (CFUs)/ml From Day 0 to Day 28 of TIP Treatment. — -1.4 CFU/ml log10
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- TOBI (Drug)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Unity Health Toronto
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change in Sputum Density of BCC in Colony Forming Units (CFUs)/ml From Day 0 to Day 28 of TIP Treatment. |
-1.4 | — |
| SECONDARY 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. |
4.6 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02212587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.