Clinical trial NCT02494076: Positive Expiratory Pressure for the Treatment of Acute Asthma in Children
Official title: Positive Expiratory Pressure for the Treatment of Acute Asthma Exacerbations in Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-07-10
Enrollment: 52
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Pulmonary Asthma Score (PAS)
timeFrame: 0-30 minutes
Secondary outcomes:
measure: Number of Participants Requiring Second Line Therapies Including Continuous Albuterol, Subcutaneous Terbutaline, IV Magnesium and Supplemental Oxygen After Administration of Intervention or Control
timeFrame: participants will be followed for the duration of ED stay, an expected average of 6-8 hours
measure: Rate of Inpatient Hospitalization
timeFrame: After intervention or control and until follow-up phone call 72 hours after disposition
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Childrens Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Nidhya Navanandan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Navanandan N, Federico M, Mistry RD. Positive Expiratory Pressure for the Treatment of Acute Asthma Exacerbations: A Randomized Controlled Trial. J Pediatr. 2017 Jun;185:149-154.e2. doi: 10.1016/j.jpeds.2017.02.032. Epub 2017 Mar 8.