Back to resultsTobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex
Primary Purpose
Cystic Fibrosis, Burkholderia Cepacia Infection
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
TOBI
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring inhaled antibiotics
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.
Sites / Locations
- St. Michael's Hospital
- Hospital for Sick Children
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TOBI Podhaler
Arm Description
Outcomes
Primary Outcome Measures
The Change in Sputum Density of BCC in Colony Forming Units (CFUs)/ml From Day 0 to Day 28 of TIP Treatment.
The change in sputum density of BCC in colony forming units (CFUs)/ml from day 0 to day 28 of TIP treatment. Sputum density was calculated by doing serial dilutions of sputum on agar plates and counting colony forming units expressed per ml.
Secondary Outcome Measures
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.
The main lung function measure was relative change in FEV1 from day 0 to Day 28 reported as %.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02212587
Brief Title
Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex
Official Title
Pilot Study of the in Vivo Efficacy of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 fibrosis patient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Burkholderia Cepacia Infection
Keywords
inhaled antibiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TOBI Podhaler
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TOBI
Intervention Description
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
Primary Outcome Measure Information:
Title
The Change in Sputum Density of BCC in Colony Forming Units (CFUs)/ml From Day 0 to Day 28 of TIP Treatment.
Description
The change in sputum density of BCC in colony forming units (CFUs)/ml from day 0 to day 28 of TIP treatment. Sputum density was calculated by doing serial dilutions of sputum on agar plates and counting colony forming units expressed per ml.
Time Frame
0 to 28 days
Secondary Outcome Measure Information:
Title
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.
Description
The main lung function measure was relative change in FEV1 from day 0 to Day 28 reported as %.
Time Frame
0 to 28 days
Other Pre-specified Outcome Measures:
Title
The Change in the Measurement of Markers of Pulmonary Inflammation (Neutrophil Counts, Neutrophil Elastase and IL-8 Levels in Sputum) Measured at Day 0 and Day 28 of TIP Treatment.
Description
We measured both neutrophil elastase sputum for participants.
Time Frame
0 to 28 days
Title
Trough and Peak Sputum Tobramycin Concentration Measured on Day 28 of TIP Treatment.
Description
We did trough (0 hour) and peak (1 hour post dose) TIP sputum tobramycin concentrations and reported it for participants.
Time Frame
Day 28
Title
The Change in BCC Planktonic and Biofilm MICs to Tobramycin Measured on Day 0 and on Day 28 of TIP Treatment.
Description
For all participants, the minimum inhibitory concentration of tobramycin for planktonic and biofilm grown BCC was measured in the lab on the isolate collected before and after TIP treatment.
Time Frame
0 to 28 days
Title
The Number of Participants With Adverse Events Measured at Day 14 and at Day 28 of TIP Treatment.
Description
The number of participants with adverse events was reported for all participants in the trial.
Time Frame
At Dat 0, Day 14, and Day 28
Title
The Change in the Measurement of Markers of Pulmonary Inflammation (Neutrophil Counts, Neutrophil Elastase and IL-8 Levels in Sputum) Measured at Day 0 and Day 28 of TIP Treatment.
Description
We measured both IL-8 sputum for participants.
Time Frame
0 to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Waters, MD
Organizational Affiliation
Hospital of Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
28262569
Citation
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.
Results Reference
result
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Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex
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