Conditions: Cystic Fibrosis
Keywords: Human factors, TOBI® Podhaler™, Instructions For use, IFU, CF patients
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 45
Healthy volunteers: no

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.

Arms:
arm 1: one dose (4 capsules) of placebo

Interventions: intervention 1: Placebo intervention 2: Tobi Podhaler
Intervention descriptions: intervention 1: one dose (4 capsules) of placebo intervention 2: 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

Protocol document: