A Phase 4 interventional study of Placebo and Tobi Podhaler in Cystic Fibrosis, sponsored by Mylan Inc.. Completed at 9 sites in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2022-03-03.
Sponsored by Mylan Inc. · Phase 4, Interventional, and Other
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 47 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Mylan Inc. is the lead sponsor of 43 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 9 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One dose (4 capsules) of placebo
Drug: Placebo · Device: Tobi Podhaler
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
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
| Milestone | Open-Label Placebo |
|---|---|
| Started | 47 |
| Completed | 45 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Screen failure | 1 |
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
| Participants | Open-Label Placebo |
|---|---|
| Number of Participants With Critical Use Errors and Close Calls Associated With the Simulated Inhalation of One Dose Using TOBI Podhaler | 4 |
Collected over Adverse events were collected from time of signing Informed Consent through completion of their study visit, 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open-Label Placebo | 0/45 (0%) | 0/45 (0%) | 1/45 (2.2%) |
| Event | Open-Label Placebo |
|---|---|
| Subject Accidentally Kicked Himself Causing A Wart To Bleed On His LegInjury, poisoning and procedural complications | 1/45 |
| Wart On LegNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/45 |
| Wart Bleed On LegInjury, poisoning and procedural complications | 1/45 |
| Age, Continuous(years) | Open-Label Placebo |
|---|---|
| Mean | 17.5 ± 12.55 |
| Sex: Female, Male(Participants) | Open-Label Placebo |
|---|---|
| Female | 21 |
| Male | 24 |
| Ethnicity (NIH/OMB)(Participants) | Open-Label Placebo |
|---|---|
| Hispanic or Latino | 9 |
| Not Hispanic or Latino | 36 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Open-Label Placebo |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 41 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
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Mylan Inc.