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Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules

Cystic Fibrosis Clinical Trial

Official title:
A Multicenter, Human Factors Validation Study in Cystic Fibrosis Patients Aged 6 Years and Older to Evaluate the User Interface of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo Capsules

Clinical Trial Summary

The purpose of this study is to validate the user interface of TOBI Podhaler by establishing that the product can support safe and effective use for the intended users

Clinical Trial Description

The objective is to conduct a human factors validation study to demonstrate that the user interface of TOBI® Podhaler™ can support safe and effective use for the intended users. The human factors validation study will be conducted in patients with cystic fibrosis aged 6 years and older under simulated yet representative of realistic use conditions where patients with no prior training or use of TOBI® Podhaler™ will be asked to inhale the contents of placebo capsules through the Podhaler device. Due to the use of placebo capsules, the study is considered an interventional clinical study and will be conducted accordingly. The study is an open label, un-blinded, non-randomized study which consists of one visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03502070
Study type Interventional
Source Viatris Inc.
Contact
Status Completed
Phase Phase 4
Start date June 26, 2018
Completion date June 17, 2019
View Details
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