Trial Outcomes & Findings for Breath-Actuated Nebulizer Versus Conventional Continuous-Output Nebulizer in Pediatric Asthma Patients (NCT NCT01045174)

Results Overview

Number (and percentage) of children in each study group requiring admission to the hospital for asthma exacerbation/status asthmaticus from the Pediatric Emergency Department (as opposed to being discharged to home)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

180 participants

Primary outcome timeframe

24 hours (whether patient is admitted after presenting to emergency department for asthma or discharged home)

Results posted on

2020-11-25

Participant Flow

Study participants recruited from eligible children who presented to a pediatric emergency department at the single study site with acute asthma exacerbation/status asthmaticus. Recruitment for this study is now closed.

180 participants were enrolled in the study. No enrolled participants were excluded from the study before assignment to groups.

Participant milestones

Participant milestones
Measure	Breath-Actuated Nebulizer Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices.	Conventional Continuous-ouput Nebulizer Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices.
Overall Study STARTED	90	90
Overall Study COMPLETED	90	90
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Breath-Actuated Nebulizer n=90 Participants Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices.	Conventional Continuous-ouput Nebulizer n=90 Participants Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices.	Total n=180 Participants Total of all reporting groups
Age, Categorical <=18 years	90 Participants n=90 Participants	90 Participants n=90 Participants	180 Participants n=180 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=90 Participants	0 Participants n=90 Participants	0 Participants n=180 Participants
Age, Categorical >=65 years	0 Participants n=90 Participants	0 Participants n=90 Participants	0 Participants n=180 Participants
Age, Continuous	6.6 years n=90 Participants	6.7 years n=90 Participants	6.65 years n=180 Participants
Sex: Female, Male Female	46 Participants n=90 Participants	44 Participants n=90 Participants	90 Participants n=180 Participants
Sex: Female, Male Male	44 Participants n=90 Participants	46 Participants n=90 Participants	90 Participants n=180 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	90 participants n=90 Participants	90 participants n=90 Participants	180 participants n=180 Participants

PRIMARY outcome

Timeframe: 24 hours (whether patient is admitted after presenting to emergency department for asthma or discharged home)

Number (and percentage) of children in each study group requiring admission to the hospital for asthma exacerbation/status asthmaticus from the Pediatric Emergency Department (as opposed to being discharged to home)

Outcome measures

Outcome measures
Measure	Breath-Actuated Nebulizer n=90 Participants Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices.	Conventional Continuous-ouput Nebulizer n=90 Participants Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices.
Rate of Admission to Hospital for Asthma Exacerbation	33 Participants	44 Participants

SECONDARY outcome

Timeframe: only measures length of stay in emergency department on date of presentation

Length of stay in the emergency department measured in minutes; up to 400 minutes measured

Outcome measures

Outcome measures
Measure	Breath-Actuated Nebulizer n=90 Participants Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices.	Conventional Continuous-ouput Nebulizer n=90 Participants Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices.
Length of Stay in the Emergency Department After Presenting for Asthma Exacerbation	162 minutes Interval 90.0 to 375.0	178 minutes Interval 94.0 to 300.0

SECONDARY outcome

Timeframe: within time frame of emergency department stay (up to 400 minutes from initial presentation to pediatric ED)

Percentage of patients (or caregivers of younger children) who "agreed" or "strongly agreed" on a brief survey (using a 5-point Likert scale) that they would feel comfortable with using the same nebulizer device to take asthma treatments in the future. Likert-type scale was used, on which score of 1=strongly disagree, 2=disagree, 3=neither agree nor disagree (or unsure), 4=agree, and 5=strongly agree.

Outcome measures

Outcome measures
Measure	Breath-Actuated Nebulizer n=90 Participants Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices.	Conventional Continuous-ouput Nebulizer n=90 Participants Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices.
Patient's Satisfaction With Using Assigned Nebulizer (as Assessed by Brief Survey)	76 Participants	55 Participants

SECONDARY outcome

Timeframe: number of children who had difficulty using assigned nebulizer device during the timeframe of the ED visit during which the study nebulizer was used. Timeframe for outcome measure was length of single emergency department visit, up to 400 minutes.

Outcome measures

Outcome measures
Measure	Breath-Actuated Nebulizer n=90 Participants Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices.	Conventional Continuous-ouput Nebulizer n=90 Participants Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer Nebulizer (breath-actuated versus conventional continuous-output): Participants randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol used in both devices.
Difficulty (if Any) Encountered by Patients With Using Assigned Nebulizer Device	0 Participants	0 Participants

Adverse Events

Breath-Actuated Nebulizer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Continuous-ouput 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

Dr. Jerri Rose

University Hospitals Cleveland Medical Center

Phone: 216-844-7147

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place