Overview

This trial is active, not recruiting.

Condition asthma
Treatments ezpap, standard care
Phase phase 4
Sponsor University of Colorado, Denver
Start date October 2014
End date May 2016
Trial size 71 participants
Trial identifier NCT02494076, 14-1106

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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 Positive Expiratory Pressure (PEP)
(Sham Comparator)
Patients randomized to the control arm will receive first-line therapies and standard therapy.
standard care

Primary Outcomes

Measure
Change in Pulmonary Asthma Score (PAS)
time frame: 0-30 minutes

Secondary Outcomes

Measure
Need for additional second line therapies after administration of intervention or control
time frame: participants will be followed for the duration of ED stay, an expected average of 6-8 hours
Rate of inpatient hospitalization
time frame: After intervention or control and until follow-up phone call 72 hours after disposition

Eligibility Criteria

Male or female participants from 2 years up to 18 years old.

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)

Additional Information

Official title Positive Expiratory Pressure for the Treatment of Acute Asthma Exacerbations in Children: A Randomized Controlled Trial
Principal investigator Nidhya Navanandan, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.