Trial Outcomes & Findings for Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules (NCT NCT03502070)
NCT ID: NCT03502070
Last Updated: 2022-03-03
Results Overview
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
COMPLETED
PHASE4
47 participants
1 Day
2022-03-03
Participant Flow
Participant milestones
| Measure |
Open-Label Placebo
One dose (4 capsules) of placebo
Placebo: One dose (4 capsules) of placebo
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
|
|---|---|
|
Overall Study
STARTED
|
47
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Open-Label Placebo
One dose (4 capsules) of placebo
Placebo: One dose (4 capsules) of placebo
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
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Screen Failure
|
1
|
Baseline Characteristics
Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules
Baseline characteristics by cohort
| Measure |
Open-Label Placebo
n=45 Participants
One dose (4 capsules) of placebo
Placebo: One dose (4 capsules) of placebo
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
|
|---|---|
|
Age, Continuous
|
17.5 years
STANDARD_DEVIATION 12.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 DayCritical 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
Outcome measures
| Measure |
Open-Label Placebo
n=45 Participants
One dose (4 capsules) of placebo
Placebo: One dose (4 capsules) of placebo
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
|
|---|---|
|
Number of Participants With Critical Use Errors and Close Calls Associated With the Simulated Inhalation of One Dose Using TOBI Podhaler
|
4 Participants
|
Adverse Events
Open-Label Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open-Label Placebo
n=45 participants at risk
One dose (4 capsules) of placebo
Placebo: One dose (4 capsules) of placebo
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
|
|---|---|
|
Injury, poisoning and procedural complications
Subject Accidentally Kicked Himself Causing A Wart To Bleed On His Leg
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of their study visit, 1 day
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Wart On Leg
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of their study visit, 1 day
|
|
Injury, poisoning and procedural complications
Wart Bleed On Leg
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from time of signing Informed Consent through completion of their study visit, 1 day
|
Additional Information
Keri L Vaughan
Director Global Clinical Operations, General Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60