At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 47 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 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
In Brief
A Phase 4 clinical trial evaluating Placebo and Tobi Podhaler for Cystic Fibrosis. Completed, enrolled 47 participants across 9 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20192020202120222023202420252026
First PostedApr 2018
Enrollment StartJun 2018
Primary CompletionMar 2019
Study CompletionJun 2019
TodayJul 2026
First PostedApr 18, 2018
Enrollment StartJun 26, 2018
Primary CompletionMar 19, 2019
Study CompletionJun 17, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.2 years ago
Interventions
Placebodrug
One dose (4 capsules) of placebo
Tobi Podhalerdevice
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