Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multi-center, Human Factors Engineering (HFE) Usability Study in Cystic Fibrosis Patients to Validate the Approved Instructions for Use (IFU) of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo Capsules

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Drug: Placebo
* Device: Tobi Podhaler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects aged 6 years and older at screening Confirmed diagnosis of CF Pulmonary function FEV1 value at least 25% of normal predicted values Must be physically and cognitively able to read, alone or with the assistance of their caregiver Exclusion Criteria: Subjects currently enrolled in studies that are not considered observational noninvestigational studies. Subjects who have used the Podhaler device previously Hemoptysis more than 60mL at any time within 30 days prior to study drug administration History of hypersensitivity to inhaled dry powder Signs and symptoms of acute pulmonary disease, e.g., pneumonia, pneumothorax

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open label<br>one dose (4 capsules) of placebo | Drug: Placebo<br>* one dose (4 capsules) of placebo<br>Device: Tobi Podhaler<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human factors, TOBI® Podhaler™, Instructions For use, IFU, CF patients