Positive Expiratory Pressure for the Treatment of Acute Asthma in Children

Positive Expiratory Pressure for the Treatment of Acute Asthma Exacerbations in Children: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: Standard Care; Drug: EzPAP

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Childrens Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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. 4 cycles is considered one time administration.	Drug: EzPAP; Other Names: Positive Expiratory Pressure (PEP)
SHAM_COMPARATOR: Standard care; Patients randomized to the control arm will receive first-line therapies and standard therapy.	Other: Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	participants will be followed for the duration of ED stay, an expected average of 6-8 hours
Rate of Inpatient Hospitalization	Number of patients in each group requiring hospital admission	After intervention or control and until follow-up phone call 72 hours after disposition

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Nidhya Navanandan, MD, University of Colorado, Denver

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): April 12, 2017

Study Registration Dates

• First Submitted: October 28, 2014
• First Submitted That Met QC Criteria: July 7, 2015
• First Posted (ESTIMATE): July 10, 2015

Study Record Updates

• Last Update Posted (ACTUAL): December 8, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 14-1106