Positive Expiratory Pressure for the Treatment of Acute Asthma in Children

NCT ID: NCT02494076

Last Updated: 2017-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-04-12

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

EzPAP

Intervention Type: DRUG

Standard care

Patients randomized to the control arm will receive first-line therapies and standard therapy.

Group Type: SHAM_COMPARATOR

Standard Care

Intervention Type: OTHER

Interventions

EzPAP

Intervention Type: DRUG

Standard Care

Intervention Type: OTHER

Other Intervention Names

Positive Expiratory Pressure (PEP)

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)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nidhya Navanandan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Childrens Hospital Colorado

Aurora, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28284473 (View on PubMed)

Other Identifiers

14-1106

Identifier Type: -

Identifier Source: org_study_id