Trial Outcomes & Findings for Effectiveness of the Aeroneb in Acute Severe Asthma (NCT NCT03029156)
NCT ID: NCT03029156
Last Updated: 2023-05-19
Results Overview
Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
30 minutes
Results posted on
2023-05-19
Participant Flow
Participant milestones
| Measure |
Small Volume Jet Nebulizer
Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.
The bronchodilators will be administered via small volume jet nebulizer
|
Aeroneb Nebulizer
Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of the Aeroneb in Acute Severe Asthma
Baseline characteristics by cohort
| Measure |
Small Volume Jet Nebulizer
n=15 Participants
Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.
The bronchodilators will be administered via small volume jet nebulizer
|
Aeroneb Nebulizer
n=16 Participants
Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 8.46 • n=99 Participants
|
39.9 years
STANDARD_DEVIATION 9.05 • n=107 Participants
|
36 years
STANDARD_DEVIATION 8.75 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 minutesPeak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration.
Outcome measures
| Measure |
Small Volume Jet Nebulizer
n=15 Participants
Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.
The bronchodilators will be administered via small volume jet nebulizer
|
Aeroneb Nebulizer
n=16 Participants
Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).
|
|---|---|---|
|
Percentage Change in Mean of Peak Expiratory Flow Rate (PEFR) Percentage of Predicted Baseline at 30 Minutes After the Initial Bronchodilator Treatment
|
18.1 percent change
Standard Deviation 18.01
|
12.9 percent change
Standard Deviation 13.36
|
SECONDARY outcome
Timeframe: Initial bronchodilator treatment to disposition, an average of 4 hoursChange in the PEFR percent predicted from the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group.
Outcome measures
| Measure |
Small Volume Jet Nebulizer
n=15 Participants
Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.
The bronchodilators will be administered via small volume jet nebulizer
|
Aeroneb Nebulizer
n=16 Participants
Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).
|
|---|---|---|
|
Percentage Change in the PEFR Percentage of Predicted Baseline to Disposition
|
23.3 percent change
Standard Deviation 15.15
|
14.4 percent change
Standard Deviation 14.04
|
SECONDARY outcome
Timeframe: initial bronchodilator treatment to disposition, an average of 4 hoursForced expiratory volume refers to the volume of air that an individual can exhale during a forced breath in 1 second.
Outcome measures
| Measure |
Small Volume Jet Nebulizer
n=15 Participants
Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.
The bronchodilators will be administered via small volume jet nebulizer
|
Aeroneb Nebulizer
n=16 Participants
Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).
|
|---|---|---|
|
Percentage Change in the Forced Expiratory Volume (FEV1) Percentage of Predicted Baseline to Disposition
|
17.1 percent change
Standard Deviation 13.05
|
8.0 percent change
Standard Deviation 8.08
|
SECONDARY outcome
Timeframe: initial bronchodilator treatment to disposition, an average of 4 hoursThe Borg-Dyspnea score measures an individual's effort, exertion, breathlessness and fatigue during physical work. This scale ranges from 6-20 with 6 representing no exertion at all and 20 representing maximal exertion.
Outcome measures
| Measure |
Small Volume Jet Nebulizer
n=15 Participants
Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.
The bronchodilators will be administered via small volume jet nebulizer
|
Aeroneb Nebulizer
n=16 Participants
Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).
|
|---|---|---|
|
Change in the Borg-Dyspnea Score From Baseline to Disposition
|
2.44 score on a scale
Standard Deviation 0.12
|
3.15 score on a scale
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: The initial bronchodilator treatment to to disposition, an average of 4 hoursChange in the heart rate at baseline after the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group.
Outcome measures
| Measure |
Small Volume Jet Nebulizer
n=15 Participants
Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.
The bronchodilators will be administered via small volume jet nebulizer
|
Aeroneb Nebulizer
n=16 Participants
Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).
|
|---|---|---|
|
Change in Heart Rate Baseline to Disposition
|
1 Change in heart rate (beats/min)
Standard Deviation 3
|
1 Change in heart rate (beats/min)
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Length of stay in the ER - up to one dayTotal length from admission to discharge.
Outcome measures
| Measure |
Small Volume Jet Nebulizer
n=15 Participants
Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.
The bronchodilators will be administered via small volume jet nebulizer
|
Aeroneb Nebulizer
n=16 Participants
Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).
|
|---|---|---|
|
Length of Stay in the ER
|
272.3 minutes
Standard Deviation 123.74
|
245.3 minutes
Standard Deviation 139.36
|
SECONDARY outcome
Timeframe: Length of stay in the ER - up to one dayTotal amount of patients requiring hospitalization after ER admission.
Outcome measures
| Measure |
Small Volume Jet Nebulizer
n=15 Participants
Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.
The bronchodilators will be administered via small volume jet nebulizer
|
Aeroneb Nebulizer
n=16 Participants
Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).
|
|---|---|---|
|
Percentage of Patients Requiring Hospitalization
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Length of stay in the ER - up to one dayAlbuterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chronic obstructive pulmonary disease.
Outcome measures
| Measure |
Small Volume Jet Nebulizer
n=15 Participants
Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.
The bronchodilators will be administered via small volume jet nebulizer
|
Aeroneb Nebulizer
n=16 Participants
Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).
|
|---|---|---|
|
The Total Dose of Albuterol Used in Each Group During ED Stay
|
6.3 dosage (mg)
Standard Deviation 2.97
|
7.2 dosage (mg)
Standard Deviation 4.07
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Length of stay in the ER - up to one dayIpratropium is used to prevent wheezing, shortness of breath, coughing and chest tightness in people with chronic obstructive pulmonary disease, chronic bronchitis, and emphysema. It is a bronchodilator which relaxes and opens the air passages to the lungs to make breathing easier.
Outcome measures
| Measure |
Small Volume Jet Nebulizer
n=15 Participants
Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.
The bronchodilators will be administered via small volume jet nebulizer
|
Aeroneb Nebulizer
n=16 Participants
Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).
|
|---|---|---|
|
The Total Dose of Ipratropium Used in Each Group During ED Stay
|
1 dosage (mg)
Standard Deviation 0.44
|
1.1 dosage (mg)
Standard Deviation 0.56
|
Adverse Events
Small Volume Jet Nebulizer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aeroneb 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place