Positive Expiratory Pressure for the Treatment of Acute Asthma in Children

NCT02494076 | Completed Phase 4 Results

• 1 other identifier: 14-1106
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants Requiring Second Line Therapies Including Continuous Albuterol, Subcutaneous Terbutaline, IV Magnesium and Supplemental Oxygen After Administration of Intervention or Control

  participants will be followed for the duration of ED stay, an expected average of 6-8 hours

• Rate of Inpatient Hospitalization

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

Study Arms (2)

EzPAP

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. 4 cycles is considered one time administration.

Drug: EzPAP

Standard care

SHAM COMPARATOR

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

Other: Standard Care

Interventions

EzPAP DRUG

Also known as: Positive Expiratory Pressure (PEP)

EzPAP

Standard Care OTHER

Standard care

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 28284473 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Positive-Pressure Respiration; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Specific PEP parameters were used that may not have been ideal for the study population. PEP was administered only once. 4 cycles is considered a one time administration. Subsequent administrations were not performed.

Results Point of Contact

• Title: Nidhya Navanandan, MD
• Organization: University Colorado School of Medicine, Chidren's Hospital Colorado

nidhya.navanandan@childrenscolorado.org

847-636-0817

Study Officials

• Nidhya Navanandan, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: July 10, 2015
• Study Start: October 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: April 12, 2017
• Last Updated: December 8, 2017
• Results First Posted: October 31, 2017

Record last verified: 2017-11

Locations

US (1)