Budesonide Inhalation Suspension for Acute Asthma in Children - Full Text View

Sponsored by:	Children's Hospital of Philadelphia
Information provided by:	Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT00393367

Purpose

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.

Condition	Intervention	Phase
Asthma Acute Asthma Reactive Airway Exacerbation	Drug: Budesonide inhalation suspension (0.5 mg/2mL)	Phase IV

MedlinePlus related topics: Asthma

Drug Information available for: Ipratropium bromide Budesonide Ipratropium Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Budesonide Inhalation Suspension for Acute Asthma in Children

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:

Median asthma score at 2 hours. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hospital admission rates. [ Time Frame: within 4 hours ] [ Designated as safety issue: No ]
Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Heart rate. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Respiratory rate. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Oxygen saturation. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Time to discharge from the Emergency Department to home. [ Time Frame: 2 to 4 hours ] [ Designated as safety issue: No ]
Relapse / readmission rates. [ Time Frame: within 5 days ] [ Designated as safety issue: No ]
Adverse reactions. [ Time Frame: within 0 - 5 days ] [ Designated as safety issue: Yes ]

Enrollment:	180
Study Start Date:	December 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator standardized treatment with nebulized BIS versus standardized treatment with nebulized saline	Drug: Budesonide inhalation suspension (0.5 mg/2mL) participants will receive standard therapy including systemic corticosteroids (SCS,albuterol and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS (inhalation suspension 0.5mg/2ml)or saline

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.

Eligibility

Ages Eligible for Study:	2 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393367

Locations

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

Sponsors and Collaborators

Children's Hospital of Philadelphia

Investigators

Principal Investigator:	Cynthia J Mollen, M.D.	Children's Hospital of Philadelphia
Study Director:	Bryan D. Upham, M.D.	University of New Mexico Children's Hospital

More Information

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.

Responsible Party:	Children's Hospital of Philadelphia ( Cynthia J. Mollen, MD )
Study ID Numbers:	2006-8-4875
Study First Received:	October 25, 2006
Last Updated:	April 28, 2008
ClinicalTrials.gov Identifier:	NCT00393367 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:

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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Neurotransmitter Agents
Cholinergic Antagonists
Bronchial Diseases
Hormone Antagonists
Albuterol
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Asthma
Cholinergic Agents
Hormones

Glucocorticoids
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Ipratropium
Bromides
Lung Diseases
Hypersensitivity, Immediate
Emergencies
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cholinergic Agents
Hormones
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses

Immune System Diseases
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Ipratropium
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009