Asthma
Conditions
Keywords
pediatrics, metered dose inhalers, breath actuated nebulizers
Brief summary
This study is determines if metered dose inhalers are as effective as breath actuated nebulizers for the treatment of mild to moderate asthma exacerbations in pediatric patients presenting to the emergency department. Half of the participating patients received albuterol via the metered dose inhaler whereas the other half received albuterol via the breath actuated nebulizer.
Detailed description
Albuterol administered via metered dose inhalers with spacers are more effective than small volume nebulizers in the treatment of acute pediatric asthma exacerbations. There is also supporting data that the breath actuated nebulizers are also more effective than small volume nebulizers. The effectiveness of breath actuated nebulization compared to MDI for treating asthma exacerbations is less well defined. Metered dose inhalers with spacers are more readily available to the general population, are easily transportable and do not require a power source. Demonstrating equal effectiveness of albuterol delivery systems for treatment of acute pediatric asthma exacerbations would enable physicians to confidently utilize clinical encounters as opportunities to educate families on management of asthma exacerbations using their home appliance.
Interventions
DEVICEMetered Dose Inhaler
A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths.
The breath actuated nebulizer (BAN) device is a device that converts liquid medication, in this case albuterol, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be attached to a mask and set to continuous nebulization for patients that are not able to coordinate their breaths.
Sponsors
University of Tennessee
Le Bonheur Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Patients presenting either with a first time wheeze or with an asthma exacerbation of a mild to moderate severity, both defined by a pediatric asthma score (PAS)11 of 5 to 11.
Exclusion criteria
* Subjects were excluded if they had initiated therapy at an outlying medical facility or had a history of any chronic lung disease * Congenital heart disease, tracheostomy, or were receiving diuretic therapy. * Patients diagnosed by the treating physician with bronchiolitis or pneumonia were excluded along with children who were wards of the state or whose parents did not speak English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participant's Admitted to the Hospital for Further Treatment | 6 hours | Patient disposition is measured as subjects requiring further treatment and being admitted to hospital. We record the number of patients in each cohort that required admission to the hospital after being evaluated and treated in the Emergency Department. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Tachycardia After Treatment | 6 hours | Defined as anytime after initiation of therapy when the patient's heart rate exceeded age adjusted normal sinus rhythm heart rates for their age. Not uncommonly, patient's experience tachycardia as an unintended side effect of receiving albuterol. Tachycardia can result in a patient requiring further observation in the Emergency department and therefore increasing Emergency Department length of stay. We want to determine if indeed tachycardia is unavoidable, or if its presence suggests that patients are receiving too much albuterol or if albuterol is being given by the wrong appliance. |
| Emergency Department Length of Stay | 6 hours | Emergency department length of stay is defined as the point of time when the patient checked into the Emergency Department to the time of final disposition. |
| Number of Patients Requiring Ondansetron Dosing | 6 hours | Defined as a patient needing ondansetron for symptomatic relief of their nausea after initiating therapy in the Emergency Department. |
| Number of Participants Requiring Repeat Visits | Within 7 days of initial presentation | Defined as a repeat visit to the Emergency Department for a complaint related to their wheezing, within 7 days of initial enrollment in the study. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Albuterol by Metered Dose Inhaler Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.
Metered Dose Inhaler: A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths. | 445 |
| Albuterol Breath Actuated Nebulizer Subjects randomized to BAN were evaluated for proper breath actuation technique. The device settings were changed to provide continuous nebulization with a facemask if the patient could not breath actuate. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.
Breath Actuated Nebulizer: The breath actuated nebulizer (BAN) device is a device that converts liquid medication, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be attached to a mask and set to continuous nebulization for patients that are not able to coordinate their breaths. | 445 |
| Total | 890 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Assent form violation | 21 | 23 |
| Overall Study | Consent form violation | 14 | 12 |
| Overall Study | Protocol Violation | 8 | 12 |
Baseline characteristics
| Characteristic | Albuterol by Metered Dose Inhaler | Albuterol Breath Actuated Nebulizer | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 445 Participants | 445 Participants | 890 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6.37 years STANDARD_DEVIATION 3.9 | 6.38 years STANDARD_DEVIATION 4 | 6.37 years STANDARD_DEVIATION 3.93 |
| Pediatric Asthma Score at Presentation | 7.7 units on a scale STANDARD_DEVIATION 1.7 | 8.0 units on a scale STANDARD_DEVIATION 1.6 | 7.9 units on a scale STANDARD_DEVIATION 1.6 |
| Region of Enrollment United States | 445 participants | 445 participants | 890 participants |
| Sex: Female, Male Female | 166 Participants | 147 Participants | 313 Participants |
| Sex: Female, Male Male | 279 Participants | 298 Participants | 577 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 445 | 0 / 445 |
| other Total, other adverse events | 101 / 445 | 141 / 445 |
| serious Total, serious adverse events | 0 / 445 | 0 / 445 |
Outcome results
Primary
Number of Participant's Admitted to the Hospital for Further Treatment
Patient disposition is measured as subjects requiring further treatment and being admitted to hospital. We record the number of patients in each cohort that required admission to the hospital after being evaluated and treated in the Emergency Department.
Time frame: 6 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Albuterol by Metered Dose Inhaler | Number of Participant's Admitted to the Hospital for Further Treatment | 53 Participants admitted to the Hospital |
| Albuterol Breath Actuated Nebulizer | Number of Participant's Admitted to the Hospital for Further Treatment | 57 Participants admitted to the Hospital |
Secondary
Emergency Department Length of Stay
Emergency department length of stay is defined as the point of time when the patient checked into the Emergency Department to the time of final disposition.
Time frame: 6 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albuterol by Metered Dose Inhaler | Emergency Department Length of Stay | Mild severity | 192 minutes | Standard Deviation 96 |
| Albuterol by Metered Dose Inhaler | Emergency Department Length of Stay | Moderate severity | 232 minutes | Standard Deviation 125 |
| Albuterol Breath Actuated Nebulizer | Emergency Department Length of Stay | Mild severity | 197 minutes | Standard Deviation 90 |
| Albuterol Breath Actuated Nebulizer | Emergency Department Length of Stay | Moderate severity | 245 minutes | Standard Deviation 98 |
Secondary
Number of Participants Requiring Repeat Visits
Defined as a repeat visit to the Emergency Department for a complaint related to their wheezing, within 7 days of initial enrollment in the study.
Time frame: Within 7 days of initial presentation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Albuterol by Metered Dose Inhaler | Number of Participants Requiring Repeat Visits | 5 Participants |
| Albuterol Breath Actuated Nebulizer | Number of Participants Requiring Repeat Visits | 4 Participants |
Secondary
Number of Patients Requiring Ondansetron Dosing
Defined as a patient needing ondansetron for symptomatic relief of their nausea after initiating therapy in the Emergency Department.
Time frame: 6 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Albuterol by Metered Dose Inhaler | Number of Patients Requiring Ondansetron Dosing | 14 Participants |
| Albuterol Breath Actuated Nebulizer | Number of Patients Requiring Ondansetron Dosing | 18 Participants |
Secondary
Number of Patients With Tachycardia After Treatment
Defined as anytime after initiation of therapy when the patient's heart rate exceeded age adjusted normal sinus rhythm heart rates for their age. Not uncommonly, patient's experience tachycardia as an unintended side effect of receiving albuterol. Tachycardia can result in a patient requiring further observation in the Emergency department and therefore increasing Emergency Department length of stay. We want to determine if indeed tachycardia is unavoidable, or if its presence suggests that patients are receiving too much albuterol or if albuterol is being given by the wrong appliance.
Time frame: 6 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Albuterol by Metered Dose Inhaler | Number of Patients With Tachycardia After Treatment | 101 Participants |
| Albuterol Breath Actuated Nebulizer | Number of Patients With Tachycardia After Treatment | 141 Participants |