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The purpose of this actual use human factors (HF) study is to validate the approved US TOBI Podhaler Instructions for Use (IFU), by establishing that the IFU effectively communicates the information necessary to achieve safe and effective use of the Podhaler device.
The objective of the HF study is to determine whether cystic fibrosis patients in the US, representative of potential TOBI Podhaler users, can understand and follow the approved IFU and the extent to which the approved IFU supports safe and effective use of the Podhaler device.
This study is an 'actual use' study, in that patients will inhale the contents of placebo capsules through the Podhaler device.
Due to the use of placebo capsules, the study is considered a clinical study and will be conducted accordingly. The study is therefore a human factors observational use study conducted within a clinical study. It is an open label, unblinded, non-randomized study and consists of two visits. At visit 2 patients who are eligible will participate in a human factor assessment to determine whether or not a patient understands the IFU content and can demonstrate safe and effective use of the Podhaler device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label | Other | one dose (4 capsules) of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | one dose (4 capsules) of placebo |
| |
| Tobi Podhaler |
| Measure | Description | Time Frame |
|---|---|---|
| The Use of the Approved US TOBI Podhaler Instructions for Use (IFU) to Communicates the Information Necessary to Achieve Safe and Effective Use of the Podhaler Device | Recording all use errors and close calls associated with inhalation of one dose of TOBI Podhaler (i.e., inhaling the contents of four placebo capsules via the Podhaler device) by subjects (CF patients, and caregivers, if applicable). The study population consisted of CF patients (and caregivers) naïve to the Podhaler device and untrained in the use of the device. Assessing the root cause of use errors and close calls for 6 defined critical errors (agreed with the FDA) and establishing those which can be attributed to a lack of clarity or presence of ambiguities in the IFU content, i.e., errors attributable to a failure to understand the IFU. | 1 Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Phoenix | Arizona | 85016 | United States | ||
| Novartis Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label | one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Device |
The capsule containing the study medication has to be released from the blister card, be inserted into the Podhaler device, actuated and the study drug be inhaled according to instructions for use |
|
| Long Beach |
| California |
| 90806 |
| United States |
| Novartis Investigative Site | Los Angeles | California | 90027 | United States |
| Novartis Investigative Site | Ventura | California | 93003 | United States |
| Novartis Investigative Site | Washington D.C. | District of Columbia | 20010-2120 | United States |
| Novartis Investigative Site | Jacksonville | Florida | 32207 | United States |
| Novartis Investigative Site | Chicago | Illinois | 60611 | United States |
| Novartis Investigative Site | New York | New York | 10595 | United States |
| Novartis Investigative Site | Toledo | Ohio | 43606 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73104 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73112 | United States |
| Novartis Investigative Site | Portland | Oregon | 97239 | United States |
| Novartis Investigative Site | Houston | Texas | 77030 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label | one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 Use of the Approved US TOBI Podhaler Instructions for Use (IFU) to Communicates the Information Necessary to Achieve Safe and Effective Use of the Podhaler Device | Recording all use errors and close calls associated with inhalation of one dose of TOBI Podhaler (i.e., inhaling the contents of four placebo capsules via the Podhaler device) by subjects (CF patients, and caregivers, if applicable). The study population consisted of CF patients (and caregivers) naïve to the Podhaler device and untrained in the use of the device. Assessing the root cause of use errors and close calls for 6 defined critical errors (agreed with the FDA) and establishing those which can be attributed to a lack of clarity or presence of ambiguities in the IFU content, i.e., errors attributable to a failure to understand the IFU. | The Full Analysis Set (FAS) included all enrolled patients who completed an HF assessment as defined by completion of inhalation of the contents of at least one capsule and related HF assessment. | Posted | Number | Patients failing to understand IFU | 1 Day |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label (6-10) Years Old | one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule | 1 | 15 | 0 | 15 | ||
| EG001 | Total - All Participants | 1 | 45 | 0 | 45 | |||
| EG002 | Open Label (11-17)Years Old | 0 | 15 | 0 | 15 | |||
| EG003 | Open Label (>=18) Years Old | 0 | 15 | 0 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchopneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pulmonary function test decreased | Investigations | MedDRA | Systematic Assessment |
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Participating patients were naïve to the Podhaler device, and untrained in its use. Patients accessed only the approved IFU document. Open label study using placebo only, potentially impacting perception of need to complete tasks fully.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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| Title | Measurements |
|---|---|
|
| Failure to pierce any of the 4 capsules (caps)* |
|
| Failure to inhale from all 4 capsules |
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| Failure to inhale all powder from any of 4 caps† |
|