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

PHASE4CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

June 26, 2018

Primary Completion Date

March 19, 2019

Study Completion Date

June 17, 2019

Conditions
Cystic Fibrosis
Interventions
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

Trial Locations (9)

23298

VCU Children's Pavilion, Richmond

32504

Nemour's Children's Clinic - Pensacola, Pensacola

32827

Nemours Childrens Hospital, Orlando

33136

Batchelor Childrens Research Institute, Miami

University of Miami Hospital, Miami

43606

Toledo Childrens Hospital, Toledo

70112

Tulane Lakeside Hospital for Women and Children, New Orleans

73104

University of Oklahoma Health Science Center, Oklahoma City

73112

Respiratory Diseases of Children and Adolescents, Oklahoma City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mylan Inc.

INDUSTRY