NCT03502070

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Mylan Inc. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Placebo	One dose (4 capsules) of placebo
DEVICE	Tobi Podhaler	The placebo capsule has to be released from the blister card and inserted into the Podhaler device. The device is then actuated and the study drug is inhaled according to the instructions for use

Timeline

• Start date: 2018-06-26
• Primary completion: 2019-03-19
• Completion: 2019-06-17
• First posted: 2018-04-18
• Last updated: 2022-03-03
• Results posted: 2020-06-30

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study