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

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.

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