Budesonide Inhalation Suspension for Acute Asthma in Children

Children's Hospital of Philadelphia179 enrolled

Overview

The purpose of this study is to determine whether the addition of budesonide inhalation suspension (BIS) to the standard therapy of albuterol, ipratropium bromide, and systemic corticosteroids (SCS) for moderate to severe asthma flares in children reduces asthma severity more rapidly than standard therapy alone.

Context: Acute asthma is a leading cause of emergency department (ED) visits and hospitalizations. Although standard therapy for acute asthma includes systemic corticosteroids (SCS), these drugs take many hours to have an effect. Recent studies demonstrate that inhaled corticosteroids (ICS) may improve patients' asthma severity more rapidly than SCS and may decrease hospitalizations. Only a few small studies have evaluated ICS added to standard therapy for acute asthma in children. Objective: To determine if adding the nebulized steroid budesonide to standard therapy including SCS improves patients' asthma severity faster than standard therapy alone and leads to fewer hospitalizations. Study Design/Setting/Participants: A double-blind, randomized, controlled trial of budesonide inhalation suspension (BIS) versus placebo for children 2 to 18 years of age who present to a tertiary care, urban pediatric ED with a moderate to severe asthma flare. Intervention: Participants will receive standard therapy including SCS, albuterol, and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline. Study Measures: Differences in asthma scores, vital signs, and the need for hospitalization will be compared between treatment groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

179

Conditions

Asthma Acute Asthma Reactive Airway Exacerbation

Interventions

Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mgDRUG

Patients randomized to budesonide inhalation suspension (BIS) receive 2 nebulized albuterol sulfate (5mg/mL) doses (2mL =10mg for patients over 20kg, 1.5mL =7.5mg for patients 10-20kg) mixed with 8mL (2mg) of BIS(0.5mg/2mL). The albuterol sulfate and BIS mixture is delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM)with an oxygen flow rate of 8L/min via a tight-fitting face mask.

Prednisolone, prednisone, or methylprednisoloneDRUG

All patients are given 2mg/kg of systemic corticosteroids (max 60mg). Patients who can tolerate pills are given oral prednisone, those who cannot are given oral prednisolone, and those who cannot tolerate oral medications are given IV methylprednisolone.

Albuterol, ipratropium bromide

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Chief complaint of "respiratory distress", "asthma", "trouble breathing", or "reactive airway disease" * Males or females age 2 to 18 years * Weight greater than or equal to 10 kilograms * Two or more prior Emergency Department or primary care visits for asthma or reactive airway disease * Identified in triage as either "acute" or "critical" * Asthma score of 8 or greater * Systemic corticosteroid prescribed in the Emergency Department * English-speaking parent/guardian present * Parental/guardian permission (informed consent) and if appropriate, child assent Exclusion Criteria: * Systemic corticosteroid use in the last 30 days * Chronic lung diseases including cystic fibrosis * Sickle cell anemia * Immunodeficiency * Cardiac disease requiring surgery or medications * Adverse drug reaction or allergy to budesonide, albuterol, ipratropium bromide, prednisone, prednisolone, or methylprednisolone * Known renal or hepatic dysfunction * Exposure to varicella in the last 21 days * Impending respiratory failure requiring positive pressure ventilation * Altered level of consciousness * Suspected foreign body aspiration or croup * Prior enrollment in the study

Locations (1)

Children's Hospital of Philadelphia Emergency Department

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Median Change in Asthma Score 2 Hours After Intervention

The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator.

Time frame: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator

Mean Change in Asthma Score at 2 Hours

Time frame: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator

Secondary Outcomes

Number of Patients Hospitalized

The number of patients requiring hospital admission 4 hours after budesonide/albuterol intervention or saline/albuterol comparator. All hospitalization decisions are made at the discretion of the attending physician.

Time frame: within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo

Change in Mean Heart Rate

Mean of heart rate in beats per minute before treatment minus mean of heart rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.