Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 165476 | Other Identifier | Health Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOBI Podhaler | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOBI | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 %. | 0 to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | We measured both neutrophil elastase sputum for participants. | 0 to 28 days |
| Trough and Peak Sputum Tobramycin Concentration Measured on Day 28 of TIP Treatment. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Valerie Waters, MD | Hospital of Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada | ||
| Hospital for Sick Children |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28262569 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | sputum density measurements was calculated for all patients from Day 0 to Day 28 | Posted | Mean | Full Range | CFU/ml log10 | 0 to 28 days |
|
1 month
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Valerie Waters | Hospital of Sick Children | 416-813-1500 | valerie.waters@sickkids.ca |
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D019121 | Burkholderia Infections |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
We did trough (0 hour) and peak (1 hour post dose) TIP sputum tobramycin concentrations and reported it for participants. |
| Day 28 |
| The Change in BCC Planktonic and Biofilm MICs to Tobramycin Measured on Day 0 and on Day 28 of TIP Treatment. | 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. | 0 to 28 days |
| The Number of Participants With Adverse Events Measured at Day 14 and at Day 28 of TIP Treatment. | The number of participants with adverse events was reported for all participants in the trial. | At Dat 0, Day 14, and Day 28 |
| 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. | We measured both IL-8 sputum for participants. | 0 to 28 days |
| Toronto |
| Ontario |
| M5G 1X8 |
| Canada |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Burkholderia cenocepacia IIIA, n (%) | Count of Participants | Participants |
|
| Burkholderia cenocepacia IIIB, n (%) | Count of Participants | Participants |
|
| Burkholderia multivorans, n (%) | Count of Participants | Participants |
|
| Sputum density log10 CFU/ml, median (range) | Median | Full Range | log10 CFU/ml |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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. | The main lung function measure was relative change in FEV1 from day 0 to Day 28 reported as %. | All patients had lung function measures which were analyzed. | Posted | Mean | Full Range | relative change in FEV1 expressed as % | 0 to 28 days |
|
|
|
| Other Pre-specified | 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. | We measured both neutrophil elastase sputum for participants. | Sputum inflammatory markers were measured for 8 participants who could produce sputum. | Posted | Mean | Full Range | NE = ug/ml | 0 to 28 days |
|
|
|
| Other Pre-specified | Trough and Peak Sputum Tobramycin Concentration Measured on Day 28 of TIP Treatment. | We did trough (0 hour) and peak (1 hour post dose) TIP sputum tobramycin concentrations and reported it for participants. | We did pre and post TIP sputum tobramycin concentrations in 9 participants at Day 28 since one patient stopped taking the drug. | Posted | Median | Full Range | ug/ml | Day 28 |
|
|
|
| Other Pre-specified | The Change in BCC Planktonic and Biofilm MICs to Tobramycin Measured on Day 0 and on Day 28 of TIP Treatment. | 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. | Posted | Mean | Full Range | ug/ml (MIC50) | 0 to 28 days |
|
|
|
| Other Pre-specified | The Number of Participants With Adverse Events Measured at Day 14 and at Day 28 of TIP Treatment. | The number of participants with adverse events was reported for all participants in the trial. | We observed for adverse events in all participants and reported on those that had an adverse event. | Posted | Count of Participants | Participants | At Dat 0, Day 14, and Day 28 |
|
|
|
| Other Pre-specified | 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. | We measured both IL-8 sputum for participants. | Sputum inflammatory markers were measured for 8 participants who could produce sputum. | Posted | Mean | Full Range | IL-8 = ng/ml | 0 to 28 days |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
Not provided
Not provided
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |