Budesonide Inhalation Suspension for Acute Asthma in Children
Information source: Children's Hospital of Philadelphia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma; Acute Asthma; Reactive Airway Exacerbation
Intervention: Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg (Drug); Prednisolone, prednisone, or methylprednisolone (Drug); Albuterol, ipratropium bromide (Drug); Ipratropium bromide (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
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.
Clinical Details
Official title: Budesonide Inhalation Suspension for Acute Asthma in Children
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Median Change in Asthma Score 2 Hours After InterventionMean Change in Asthma Score at 2 Hours
Secondary outcome: Number of Patients HospitalizedChange in Mean Heart Rate Mean Change in Respiratory Rate. Oxygen Saturation. Number of Subjects Remaining in the Severe Asthma Category Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category Number of Subjects Moving From the Severe Asthma to Mild Asthma Category Relapse / Readmission Numbers. Number of Participants With Adverse Events (Non-serious). Serious Adverse Events
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
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
Locations and Contacts
Children's Hospital of Philadelphia Emergency Department, Philadelphia, Pennsylvania 19104, United States
Additional Information
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. Update in: Cochrane Database Syst Rev. 2012;12:CD002308. 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
Last updated: August 6, 2012
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