Budesonide Inhalation Suspension for Acute Asthma in Children
Condition: Asthma; Acute Asthma; Reactive Airway Exacerbation
MeSH terms: Asthma; Respiratory Aspiration
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg; Prednisolone, prednisone, or methylprednisolone; Albuterol, ipratropium bromide; Ipratropium bromide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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.; 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.; While guardians are approached for possible participation, patients are given a single nebulized dose of albuterol sulfate (5mg/mL) mixed with ipratropium bromide (500mcg/2.5mL). Patients who weigh 10-20kg receive 3.75mg of albuterol. Patients over 20kg receive 5mg of albuterol. All patients receive 500mcg of ipratropium bromide. Albuterol sulfate and ipratropium bromide are 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.; 500 mcg/2.5mL. All patients receive a final dose of ipratropium bromide after the intervention or placebo. The ipratropium bromide is delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM) with an oxygen flow rate of 8L/minute via a tight-fitting face mask.
Other intervention name(s): Pulmicort; Albuterol; Prednisolone; prednisone; methylprednisolone; Albuterol; Atrovent; Atrovent
Intervention MeSH terms: Prednisone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Budesonide; Bromides; Albuterol; Ipratropium; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Acute; Treatment; Children; Pediatric; Inhaled corticosteroid; Budesonide; Budesonide inhalation suspension; Asthma score; Emergency; Emergency Department; Asthma flare; Clinical trial; Randomized clinical trial; Randomized trial; Pulmonary index score; Hospitalization; Moderate asthma; Severe asthma; Mixing budesonide; Budesonide admixture; Albuterol; Continuous albuterol; Ipratropium bromide