Budesonide Inhalation Suspension for Acute Asthma in Children

Children's Hospital of Philadelphia (CHOP)

Status and phase: Completed; Phase 4

Conditions: Asthma; Reactive Airway Exacerbation; Acute Asthma

Treatments: Drug: Albuterol, ipratropium bromide; Drug: Ipratropium bromide; Drug: Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg; Drug: Prednisolone, prednisone, or methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT00393367

2006-8-4875

Details and patient eligibility

About

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.

Full 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.

Enrollment: 179 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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179 participants in 2 patient groups, including a placebo group

Saline Placebo

Placebo Comparator group

Description:

All subjects will receive 3 albuterol sulfate doses, 2 ipratropium bromide doses, and systemic corticosteroids. All patients will receive both the systemic corticosteroids and one dose of a mixture of albuterol and ipratropium bromide while guardians are approached for consent. Patients randomized to this placebo comparator arm will then receive 2 nebulized albuterol doses mixed with 8mL of normal saline. Finally, all patients will receive the second nebulized ipratropium dose.

Treatment:

Drug: Prednisolone, prednisone, or methylprednisolone

Drug: Ipratropium bromide

Drug: Albuterol, ipratropium bromide

Budesonide Inhalaiton Suspension

Experimental group

Description:

All subjects will receive 3 albuterol sulfate doses, 2 ipratropium bromide doses, and systemic corticosteroids. All patients will receive both the systemic corticosteroids and one dose of a mixture of albuterol and ipratropium bromide while guardians are approached for consent. Patients randomized to this intervention arm will then receive 2 nebulized albuterol doses mixed with 8mL of budesonide inhalation suspension (BIS). Finally, all patients will receive the second nebulized ipratropium dose.

Treatment:

Drug: Prednisolone, prednisone, or methylprednisolone

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

Drug: Ipratropium bromide

Drug: Albuterol, ipratropium bromide