Clinical trial NCT00393367: Budesonide Inhalation Suspension for Acute Asthma in Children
Official title: Budesonide Inhalation Suspension for Acute Asthma in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Acute Asthma
Reactive Airway Exacerbation
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
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2006-10-27
Enrollment: 179
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Median Change in Asthma Score 2 Hours After Intervention
timeFrame: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator
measure: Mean Change in Asthma Score at 2 Hours
timeFrame: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator
Secondary outcomes:
measure: Number of Patients Hospitalized
timeFrame: within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo
measure: Change in Mean Heart Rate
timeFrame: From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator
measure: Mean Change in Respiratory Rate.
timeFrame: Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator
measure: Oxygen Saturation.
timeFrame: 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator
measure: Number of Subjects Remaining in the Severe Asthma Category
timeFrame: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator
measure: Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category
timeFrame: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator
measure: Number of Subjects Moving From the Severe Asthma to Mild Asthma Category
timeFrame: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator
measure: Relapse / Readmission Numbers.
timeFrame: within 5 days of ED visit
measure: Number of Participants With Adverse Events (Non-serious).
timeFrame: within 30 days of the ED visit
measure: Serious Adverse Events
timeFrame: 0-5 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia Emergency Department
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Cynthia J Mollen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Mexico Children's Hospital
name: Bryan D. Upham, M.D.
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1002/14651858.CD002308.
citation: 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. doi: 10.1056/NEJM199810083391503.
citation: 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. doi: 10.1111/j.1553-2712.1998.tb02614.x.
citation: 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. doi: 10.1080/08035259950168748.
citation: 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. doi: 10.1016/s0196-0644(95)70118-4.
citation: 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.
citation: 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. doi: 10.1056/NEJM200009073431003.