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NCT Number: NCT02494076

Positive Expiratory Pressure for the Treatment of Acute Asthma in Children

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

EzPAP

Drug

Other names: Positive Expiratory Pressure (PEP)

Standard care

Other

Primary outcomes

  1. Change in Pulmonary Asthma Score (PAS)

    Time frame: 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 outcomes

  1. Number of Participants Requiring Second Line Therapies Including Continuous Albuterol, Subcutaneous Terbutaline, IV Magnesium and Supplemental Oxygen 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

    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.

  2. Rate of Inpatient Hospitalization

    Time frame: After intervention or control and until follow-up phone call 72 hours after disposition

    Number of patients in each group requiring hospital admission

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jul 10, 2015
Registry last updated
Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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