Asthma
Conditions
Brief summary
Asthma is a leading cause of emergency department (ED) visits for children. A novel way of treating asthma is the use of positive expiratory pressure (PEP). Positive expiratory pressure works by creating pressure in the lungs to keep airways open and to clear mucus from the lungs. PEP is already used in the treatment of asthma at the investigators institution, but studies evaluating the efficacy of PEP therapy in asthma exacerbations do not exist. This study plans to learn more about the use of PEP therapy in the treatment of asthma exacerbations in children in the emergency department. Specifically, the study aims to evaluate if PEP therapy reduces the severity of asthma exacerbations in children and if it reduces the need for additional therapies and admission to the hospital. This study will be a randomized control trial comparing children who receive standard therapy to those who receive standard therapy plus PEP therapy in the treatment of asthma exacerbations. Children age 2 to 18 years presenting to the ED with moderate to severe asthma exacerbations will be included in the study. Reduction in clinical asthma severity will be measured by change in the Pulmonary Asthma Score (the respiratory severity score used at the investigators institution). The need for additional therapies and hospitalization will also be evaluated.
Interventions
DRUGEzPAP
OTHERStandard Care
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age \>= 2 and \< 18 years of age * Established diagnosis of asthma, defined as at least two prior episodes of treatment with bronchodilators in their lifetime * Initial ED presentation with a moderate to severe asthma exacerbation, as defined by a pulmonary asthma score (PAS) \>7 * PAS score \>7 and \<12 after completion of first line therapies (three doses albuterol/ipratropium bromide and oral corticosteroids)
Exclusion criteria
* Do not receive complete first line therapies * Immediately receive a disposition (admission or discharge) as determined by the treating clinician after completion of first line therapies * Receive prednisone or more than two doses of inhaled bronchodilators prior to main ED evaluation (e.g. during EMS transport or primary care visit) * Co-morbid illnesses interfering with or contraindicated to usual asthma therapy (e.g. facial or airway abnormalities, pneumonia, chronic lung disease, congenital heart disease, cystic fibrosis, or pneumothorax) * Critically ill at presentation * Pregnant women (women known to be pregnant at the time of enrollment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pulmonary Asthma Score (PAS) | 0-30 minutes | The primary outcome was the change in asthma severity as determined by change in Pulmonary Asthma Score (PAS) before and after administration of intervention (or control). The same trained, blinded physician assessor, who was not involved in the care of the patient, assessed PAS scores for study subjects before intervention (or control), and 15 minutes after completion of administration. The PAS is a pediatric asthma severity scoring system adapted from previously validated scores, and includes measures of respiratory rate, oxygen saturation, auscultory findings, retractions, and dyspnea. Values from each category are summed producing a total score between 5 and 15. Total scores \< 7 correspond with mild asthma exacerbations, while scores ≥ 7 and \< 12 indicate moderate asthma, and scores ≥12 to 15 indicate severe asthma. The primary outcome was determined by subtracting the post-intervention score from the pre-intervention score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring Second Line Therapies Including Continuous Albuterol, Subcutaneous Terbutaline, IV Magnesium and Supplemental Oxygen After Administration of Intervention or Control | participants will be followed for the duration of ED stay, an expected average of 6-8 hours | Second line therapies include: continuous albuterol, intravenous magnesium sulfate, subcutaneous or intravenous terbutaline, non-invasive ventilation (BiPAP or CPAP), and supplemental oxygen. The need for these second line therapies will be assessed by the child's treating team in the Emergency Department. |
| Rate of Inpatient Hospitalization | After intervention or control and until follow-up phone call 72 hours after disposition | Number of patients in each group requiring hospital admission |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EzPAP Patients randomized to the EzPAP arm will receive first-line therapies and PEP therapy via EzPAP. All patients will receive 4 cycles with 12 breaths per cycle.
EzPAP | 26 |
| Standard Care Patients randomized to the control arm will receive first-line therapies and standard therapy.
Standard Care | 26 |
| Total | 52 |
Baseline characteristics
| Characteristic | Standard Care | EzPAP | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 26 Participants | 26 Participants | 52 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 | 6.9 years STANDARD_DEVIATION 4.1 | 8.7 years STANDARD_DEVIATION 4.3 | 7.8 years STANDARD_DEVIATION 4.3 |
| Region of Enrollment United States | 26 Participants | 26 Participants | 52 Participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 15 Participants |
| Sex: Female, Male Male | 21 Participants | 16 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 3 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
Change in Pulmonary Asthma Score (PAS)
The primary outcome was the change in asthma severity as determined by change in Pulmonary Asthma Score (PAS) before and after administration of intervention (or control). The same trained, blinded physician assessor, who was not involved in the care of the patient, assessed PAS scores for study subjects before intervention (or control), and 15 minutes after completion of administration. The PAS is a pediatric asthma severity scoring system adapted from previously validated scores, and includes measures of respiratory rate, oxygen saturation, auscultory findings, retractions, and dyspnea. Values from each category are summed producing a total score between 5 and 15. Total scores \< 7 correspond with mild asthma exacerbations, while scores ≥ 7 and \< 12 indicate moderate asthma, and scores ≥12 to 15 indicate severe asthma. The primary outcome was determined by subtracting the post-intervention score from the pre-intervention score.
Time frame: 0-30 minutes
Population: 2 patients in EzPAP group were excluded from analysis due to protocol error and missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EzPAP | Change in Pulmonary Asthma Score (PAS) | 0.9 mean PAS score | Standard Deviation 1.2 |
| Standard Care | Change in Pulmonary Asthma Score (PAS) | 0.4 mean PAS score | Standard Deviation 1.2 |
Secondary
Number of Participants Requiring Second Line Therapies Including Continuous Albuterol, Subcutaneous Terbutaline, IV Magnesium and Supplemental Oxygen After Administration of Intervention or Control
Second line therapies include: continuous albuterol, intravenous magnesium sulfate, subcutaneous or intravenous terbutaline, non-invasive ventilation (BiPAP or CPAP), and supplemental oxygen. The need for these second line therapies will be assessed by the child's treating team in the Emergency Department.
Time frame: participants will be followed for the duration of ED stay, an expected average of 6-8 hours
Population: 2 subjects excluded from analysis due to missing data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EzPAP | Number of Participants Requiring Second Line Therapies Including Continuous Albuterol, Subcutaneous Terbutaline, IV Magnesium and Supplemental Oxygen After Administration of Intervention or Control | Continuous albuterol | 11 Participants |
| EzPAP | Number of Participants Requiring Second Line Therapies Including Continuous Albuterol, Subcutaneous Terbutaline, IV Magnesium and Supplemental Oxygen After Administration of Intervention or Control | Subcutaneous or intravenous terbutaline | 0 Participants |
| EzPAP | Number of Participants Requiring Second Line Therapies Including Continuous Albuterol, Subcutaneous Terbutaline, IV Magnesium and Supplemental Oxygen After Administration of Intervention or Control | Intravenous magnesium | 1 Participants |
| EzPAP | Number of Participants Requiring Second Line Therapies Including Continuous Albuterol, Subcutaneous Terbutaline, IV Magnesium and Supplemental Oxygen After Administration of Intervention or Control | Supplemental oxygen | 2 Participants |
| Standard Care | Number of Participants Requiring Second Line Therapies Including Continuous Albuterol, Subcutaneous Terbutaline, IV Magnesium and Supplemental Oxygen After Administration of Intervention or Control | Supplemental oxygen | 7 Participants |
| Standard Care | Number of Participants Requiring Second Line Therapies Including Continuous Albuterol, Subcutaneous Terbutaline, IV Magnesium and Supplemental Oxygen After Administration of Intervention or Control | Continuous albuterol | 15 Participants |
| Standard Care | Number of Participants Requiring Second Line Therapies Including Continuous Albuterol, Subcutaneous Terbutaline, IV Magnesium and Supplemental Oxygen After Administration of Intervention or Control | Intravenous magnesium | 3 Participants |
| Standard Care | Number of Participants Requiring Second Line Therapies Including Continuous Albuterol, Subcutaneous Terbutaline, IV Magnesium and Supplemental Oxygen After Administration of Intervention or Control | Subcutaneous or intravenous terbutaline | 1 Participants |
Secondary
Rate of Inpatient Hospitalization
Number of patients in each group requiring hospital admission
Time frame: After intervention or control and until follow-up phone call 72 hours after disposition
Population: 2 patients excluded due to missing data and protocol error
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EzPAP | Rate of Inpatient Hospitalization | 10 Participants |
| Standard Care | Rate of Inpatient Hospitalization | 13 Participants |