Phase 4
N=52
Positive Expiratory Pressure for the Treatment of Acute Asthma in Children
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02494076 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Change in Pulmonary Asthma Score (PAS) — 0.9; 0.4 mean PAS score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- EzPAP (Drug); Standard Care (Other)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pulmonary Asthma Score (PAS) |
0.9; 0.4 | — |
| SECONDARY Number of Participants Requiring Second Line Therapies Including Continuous Albuterol, Subcutaneous Terbutaline, IV Magnesium and Supplemental Oxygen After Administration of Intervention or Control |
11; 15; 0; 1; 1; 3 | — |
| SECONDARY Rate of Inpatient Hospitalization |
10; 13 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age >= 2 and 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)
Data sourced from ClinicalTrials.gov (NCT02494076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.