Budesonide Inhalation Suspension for Acute Asthma in Children

Condition(s) targeted: Asthma; Acute Asthma; Reactive Airway Exacerbation

Intervention: Budesonide inhalation suspension (0.5 mg/2mL) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Children's Hospital of Philadelphia

Official(s) and/or principal investigator(s):
Cynthia J Mollen, M.D., Principal Investigator, Affiliation: Children's Hospital of Philadelphia
Bryan D. Upham, M.D., Study Director, Affiliation: University of New Mexico Children's Hospital

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.

Official title: Budesonide Inhalation Suspension for Acute Asthma in Children

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Median asthma score at 2 hours.

Secondary outcome:

Hospital admission rates.

Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild.

Heart rate.

Respiratory rate.

Oxygen saturation.

Time to discharge from the Emergency Department to home.

Relapse / readmission rates.

Adverse reactions.

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.

Minimum age: 2 Years. Maximum age: 18 Years. Gender(s): Both.

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

Children's Hospital of Philadelphia Emergency Department, Philadelphia, Pennsylvania 19104, United States

Related publications:

Edmonds ML, Camargo CA Jr, Pollack CV Jr, Rowe BH. Early use of inhaled corticosteroids in the emergency department treatment of acute asthma. Cochrane Database Syst Rev. 2003;(3):CD002308. Review.

Qureshi F, Pestian J, Davis P, Zaritsky A. Effect of nebulized ipratropium on the hospitalization rates of children with asthma. N Engl J Med. 1998 Oct 8;339(15):1030-5.

Sung L, Osmond MH, Klassen TP. Randomized, controlled trial of inhaled budesonide as an adjunct to oral prednisone in acute asthma. Acad Emerg Med. 1998 Mar;5(3):209-13.

Devidayal, Singhi S, Kumar L, Jayshree M. Efficacy of nebulized budesonide compared to oral prednisolone in acute bronchial asthma. Acta Paediatr. 1999 Aug;88(8):835-40.

Scarfone RJ, Loiselle JM, Wiley JF 2nd, Decker JM, Henretig FM, Joffe MD. Nebulized dexamethasone versus oral prednisone in the emergency treatment of asthmatic children. Ann Emerg Med. 1995 Oct;26(4):480-6.

Nuhoglu Y, Atas E, Nuhoglu C, Iscan M, Ozcay S. Acute effect of nebulized budesonide in asthmatic children. J Investig Allergol Clin Immunol. 2005;15(3):197-200.

Schuh S, Reisman J, Alshehri M, Dupuis A, Corey M, Arseneault R, Alothman G, Tennis O, Canny G. A comparison of inhaled fluticasone and oral prednisone for children with severe acute asthma. N Engl J Med. 2000 Sep 7;343(10):689-94.

Starting date: December 2006
Ending date: November 2007
Last updated: April 28, 2008