Trial Outcomes & Findings for Comparison of Vibrating Mesh Nebulizer Versus Jet Nebulizer in the Pediatric Asthma Patient (NCT NCT02774941)
NCT ID: NCT02774941
Last Updated: 2020-01-31
Results Overview
The primary outcome measure is rate of hospitalization between the two treatment groups overall
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
220 participants
Primary outcome timeframe
Within emergency department visit time frame (no more than 12 hours)
Results posted on
2020-01-31
Participant Flow
Participant milestones
| Measure |
Control - Jet Nebulizer
The control group used our standard single patient-use small volume JN (AirLife™ Sidestream® High-Efficiency Nebulizer, CareFusion, Yorba Linda, CA) operated at 7 L/min per manufacture's guidelines.
|
Study - Vibrating Mesh Nebulizer
The study group used a VMN (Aerogen® Solo with Ultra adapter, Aerogen Ltd, Galway, Ireland) that is an electronically powered nebulizer.
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
110
|
|
Overall Study
Subjects Excluded
|
1
|
2
|
|
Overall Study
COMPLETED
|
109
|
108
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Vibrating Mesh Nebulizer Versus Jet Nebulizer in the Pediatric Asthma Patient
Baseline characteristics by cohort
| Measure |
Control - Jet Nebulizer
n=109 Participants
The control group used our standard single patient-use small volume JN (AirLife™ Sidestream® High-Efficiency Nebulizer, CareFusion, Yorba Linda, CA) operated at 7 L/min per manufacture's guidelines.
|
Study - Vibrating Mesh Nebulizer
n=108 Participants
The study group used a VMN (Aerogen® Solo with Ultra adapter, Aerogen Ltd, Galway, Ireland) that is an electronically powered nebulizer.
|
Total
n=217 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
109 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
6.0 years
n=5 Participants
|
7.0 years
n=7 Participants
|
7.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
46 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
59 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
109 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Moderate Asthma
|
63 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Severe Asthma
|
46 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within emergency department visit time frame (no more than 12 hours)The primary outcome measure is rate of hospitalization between the two treatment groups overall
Outcome measures
| Measure |
Control - Jet Nebulizer
n=109 Participants
The control group used our standard single patient-use small volume JN (AirLife™ Sidestream® High-Efficiency Nebulizer, CareFusion, Yorba Linda, CA) operated at 7 L/min per manufacture's guidelines.
|
Study - Vibrating Mesh Nebulizer
n=108 Participants
The study group used a VMN (Aerogen® Solo with Ultra adapter, Aerogen Ltd, Galway, Ireland) that is an electronically powered nebulizer.
|
|---|---|---|
|
Number of Subjects Hospitalized
|
22 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Within emergency department visit time frame (no more than 12 hours)Outcome measures
| Measure |
Control - Jet Nebulizer
n=109 Participants
The control group used our standard single patient-use small volume JN (AirLife™ Sidestream® High-Efficiency Nebulizer, CareFusion, Yorba Linda, CA) operated at 7 L/min per manufacture's guidelines.
|
Study - Vibrating Mesh Nebulizer
n=108 Participants
The study group used a VMN (Aerogen® Solo with Ultra adapter, Aerogen Ltd, Galway, Ireland) that is an electronically powered nebulizer.
|
|---|---|---|
|
Number of Treatments Required to Achieve Mild Asthma Score - Discharge Criteria
|
3.0 number of treatments
Interval 2.0 to 5.0
|
2 number of treatments
Interval 1.0 to 3.0
|
Adverse Events
Control - Jet Nebulizer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study - Vibrating Mesh Nebulizer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Research Coordinator - Respiratory Care Dept
Children's Health - Children's Medical Center, Dallas
Phone: 214-456-1367
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place