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

Phase 4

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Open label	Placebo	one dose (4 capsules) of placebo
Open label	Tobi Podhaler	one dose (4 capsules) of placebo

Primary Outcome Measures

Name	Time	Method
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	1 Day	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.

Secondary Outcome Measures