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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Tobramycin

Criteria

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