Budesonide Inhalation Suspension for Acute Asthma in Children

Asthma Clinical Trial

Official title:

Budesonide Inhalation Suspension for Acute Asthma in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00393367
• Other study ID #: 2006-8-4875
• Status: Completed
• Phase: Phase 4
• First received: October 25, 2006
• Last updated: August 6, 2012
• Start date: December 2006
• Est. completion date: November 2007

Study information

• Verified date: August 2012
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Asthma
• Asthma
• Reactive Airway Exacerbation

Intervention

Drug:
• Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg
Patients randomized to budesonide inhalation suspension (BIS) receive 2 nebulized albuterol sulfate (5mg/mL) doses (2mL =10mg for patients over 20kg, 1.5mL =7.5mg for patients 10-20kg) mixed with 8mL (2mg) of BIS(0.5mg/2mL). The albuterol sulfate and BIS mixture is delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM)with an oxygen flow rate of 8L/min via a tight-fitting face mask.
• Prednisolone, prednisone, or methylprednisolone
All patients are given 2mg/kg of systemic corticosteroids (max 60mg). Patients who can tolerate pills are given oral prednisone, those who cannot are given oral prednisolone, and those who cannot tolerate oral medications are given IV methylprednisolone.
• Albuterol, ipratropium bromide
While guardians are approached for possible participation, patients are given a single nebulized dose of albuterol sulfate (5mg/mL) mixed with ipratropium bromide (500mcg/2.5mL). Patients who weigh 10-20kg receive 3.75mg of albuterol. Patients over 20kg receive 5mg of albuterol. All patients receive 500mcg of ipratropium bromide. Albuterol sulfate and ipratropium bromide are delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM)with an oxygen flow rate of 8L/min via a tight-fitting face mask.
• Ipratropium bromide
500 mcg/2.5mL. All patients receive a final dose of ipratropium bromide after the intervention or placebo. The ipratropium bromide is delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM) with an oxygen flow rate of 8L/minute via a tight-fitting face mask.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia Emergency Department	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2012;12:CD002308. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Change in Asthma Score 2 Hours After Intervention	The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator.	Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator	No
Primary	Mean Change in Asthma Score at 2 Hours	The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator.	Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator	No
Secondary	Number of Patients Hospitalized	The number of patients requiring hospital admission 4 hours after budesonide/albuterol intervention or saline/albuterol comparator. All hospitalization decisions are made at the discretion of the attending physician.	within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo	No
Secondary	Change in Mean Heart Rate	Mean of heart rate in beats per minute before treatment minus mean of heart rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol	From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator	No
Secondary	Mean Change in Respiratory Rate.	Mean respiratory rate in breaths per minute before treatment minus respiratory rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator.	Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator	No
Secondary	Oxygen Saturation.	Mean oxygen saturation (non-invasive pulse-oximetry, % hemoglobin saturation) 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator minus mean oxygen saturation before treatment.	2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator	No
Secondary	Number of Subjects Remaining in the Severe Asthma Category	Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who remained in this category 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.	From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator	No
Secondary	Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category	Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the moderate category (Asthma Severity score 8-11) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.	From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator	No
Secondary	Number of Subjects Moving From the Severe Asthma to Mild Asthma Category	Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the mild category (Asthma Severity score 5-7) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.	From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator	No
Secondary	Relapse / Readmission Numbers.	Participants admitted to the hospital within 5 days of the ED visit	within 5 days of ED visit	No
Secondary	Number of Participants With Adverse Events (Non-serious).		within 30 days of the ED visit	Yes
Secondary	Serious Adverse Events	Serious Adverse Events	0-5 days	Yes