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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
47
One dose (4 capsules) of placebo
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
Batchelor Childrens Research Institute
Miami, Florida, United States
University of Miami Hospital
Miami, Florida, United States
Nemours Childrens Hospital
Orlando, Florida, United States
Number of Participants With Critical Use Errors and Close Calls Associated With the Simulated Inhalation of One Dose Using TOBI Podhaler
Critical use errors and close calls for the following: placing of capsule into the top of the mouthpiece, failure to replace mouthpiece, failure to adequately pierce capsule, failure to release before inhaling, multiple piercing of capsule, exhalation into mouthpiece, inadequate seal around mouthpiece, inadequate inhalation technique, failure to use reserve device when capsule not adequately pierced, failure to administer 4 capsules per dose, swallowing of capsule
Time frame: 1 Day
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Nemour's Children's Clinic - Pensacola
Pensacola, Florida, United States
Tulane Lakeside Hospital for Women and Children
New Orleans, Louisiana, United States
Toledo Childrens Hospital
Toledo, Ohio, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States
Respiratory Diseases of Children and Adolescents
Oklahoma City, Oklahoma, United States
VCU Children's Pavilion
Richmond, Virginia, United States