At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 45 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Human Factors Engineering (HFE) Usability Study in Cystic Fibrosis Patients to Validate the Approved Instructions for Use (IFU) of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo Capsules
In Brief
A Phase 4 clinical trial evaluating Placebo and Tobi Podhaler for Cystic Fibrosis. Completed, enrolled 45 participants across 13 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2014
Enrollment StartAug 2014
Primary CompletionFeb 2015
TodayJul 2026
First PostedJun 30, 2014
Enrollment StartAug 1, 2014
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.0 years ago
Interventions
Placebodrug
one dose (4 capsules) of placebo
Tobi Podhalerdevice
The capsule containing the study medication has to be released from the blister card, be inserted into the Podhaler device, actuated and the study drug be inhaled according to instructions for use