Back to resultsBudesonide Inhalation Suspension for Acute Asthma in Children
Primary Purpose
Asthma, Acute Asthma, Reactive Airway Exacerbation
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg
Prednisolone, prednisone, or methylprednisolone
Albuterol, ipratropium bromide
Ipratropium bromide
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring 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
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
Sites / Locations
- Children's Hospital of Philadelphia Emergency Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Saline Placebo
Budesonide Inhalaiton Suspension
Arm Description
All subjects will receive 3 albuterol sulfate doses, 2 ipratropium bromide doses, and systemic corticosteroids. All patients will receive both the systemic corticosteroids and one dose of a mixture of albuterol and ipratropium bromide while guardians are approached for consent. Patients randomized to this placebo comparator arm will then receive 2 nebulized albuterol doses mixed with 8mL of normal saline. Finally, all patients will receive the second nebulized ipratropium dose.
All subjects will receive 3 albuterol sulfate doses, 2 ipratropium bromide doses, and systemic corticosteroids. All patients will receive both the systemic corticosteroids and one dose of a mixture of albuterol and ipratropium bromide while guardians are approached for consent. Patients randomized to this intervention arm will then receive 2 nebulized albuterol doses mixed with 8mL of budesonide inhalation suspension (BIS). Finally, all patients will receive the second nebulized ipratropium dose.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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
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.
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.
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.
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.
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.
Relapse / Readmission Numbers.
Participants admitted to the hospital within 5 days of the ED visit
Number of Participants With Adverse Events (Non-serious).
Serious Adverse Events
Serious Adverse Events
Full Information
NCT ID
NCT00393367
First Posted
October 25, 2006
Last Updated
August 6, 2012
Sponsor
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT00393367
Brief Title
Budesonide Inhalation Suspension for Acute Asthma in Children
Official Title
Budesonide Inhalation Suspension for Acute Asthma in Children
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
179 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline Placebo
Arm Type
Placebo Comparator
Arm Description
All subjects will receive 3 albuterol sulfate doses, 2 ipratropium bromide doses, and systemic corticosteroids. All patients will receive both the systemic corticosteroids and one dose of a mixture of albuterol and ipratropium bromide while guardians are approached for consent. Patients randomized to this placebo comparator arm will then receive 2 nebulized albuterol doses mixed with 8mL of normal saline. Finally, all patients will receive the second nebulized ipratropium dose.
Arm Title
Budesonide Inhalaiton Suspension
Arm Type
Experimental
Arm Description
All subjects will receive 3 albuterol sulfate doses, 2 ipratropium bromide doses, and systemic corticosteroids. All patients will receive both the systemic corticosteroids and one dose of a mixture of albuterol and ipratropium bromide while guardians are approached for consent. Patients randomized to this intervention arm will then receive 2 nebulized albuterol doses mixed with 8mL of budesonide inhalation suspension (BIS). Finally, all patients will receive the second nebulized ipratropium dose.
Intervention Type
Drug
Intervention Name(s)
Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg
Other Intervention Name(s)
Pulmicort, Albuterol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisolone, prednisone, or methylprednisolone
Other Intervention Name(s)
Prednisolone, prednisone, methylprednisolone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Albuterol, ipratropium bromide
Other Intervention Name(s)
Albuterol, Atrovent
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ipratropium bromide
Other Intervention Name(s)
Atrovent
Intervention Description
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.
Primary Outcome Measure Information:
Title
Median Change in Asthma Score 2 Hours After Intervention
Description
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.
Time Frame
Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator
Title
Mean Change in Asthma Score at 2 Hours
Description
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.
Time Frame
Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator
Secondary Outcome Measure Information:
Title
Number of Patients Hospitalized
Description
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.
Time Frame
within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo
Title
Change in Mean Heart Rate
Description
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
Time Frame
From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator
Title
Mean Change in Respiratory Rate.
Description
Mean respiratory rate in breaths per minute before treatment minus respiratory rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator.
Time Frame
Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator
Title
Oxygen Saturation.
Description
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.
Time Frame
2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator
Title
Number of Subjects Remaining in the Severe Asthma Category
Description
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.
Time Frame
From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator
Title
Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category
Description
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.
Time Frame
From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator
Title
Number of Subjects Moving From the Severe Asthma to Mild Asthma Category
Description
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.
Time Frame
From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator
Title
Relapse / Readmission Numbers.
Description
Participants admitted to the hospital within 5 days of the ED visit
Time Frame
within 5 days of ED visit
Title
Number of Participants With Adverse Events (Non-serious).
Time Frame
within 30 days of the ED visit
Title
Serious Adverse Events
Description
Serious Adverse Events
Time Frame
0-5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia J Mollen, M.D.
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bryan D. Upham, M.D.
Organizational Affiliation
University of New Mexico Children's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Philadelphia Emergency Department
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12917930
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.
Results Reference
background
PubMed Identifier
9761804
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.
Results Reference
background
PubMed Identifier
9523927
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.
Results Reference
background
PubMed Identifier
10503681
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.
Results Reference
background
PubMed Identifier
7574132
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.
Results Reference
background
PubMed Identifier
16261956
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.
Results Reference
background
PubMed Identifier
10974132
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.
Results Reference
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Budesonide Inhalation Suspension for Acute Asthma in Children
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