Budesonide Inhalation Suspension for Acute Asthma in Children
Condition: Asthma; Acute Asthma; Reactive Airway Exacerbation
MeSH terms: Asthma; Respiratory Aspiration
Intervention: 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 description: 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.
Intervention MeSH terms: Prednisone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Budesonide; Bromides; Albuterol; Ipratropium; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 179.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        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