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Completed

NCT Number: NCT00393367

Budesonide Inhalation Suspension for Acute Asthma in Children

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.

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Key information

Conditions

Asthma Acute Asthma Bronchial Diseases Disease Attributes Emergencies Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Reactive Airway Exacerbation Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital of Philadelphia Emergency Department

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg

Drug

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.

Other names: Pulmicort, Albuterol

Prednisolone, prednisone, or methylprednisolone

Drug

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.

Other names: Prednisolone, prednisone, methylprednisolone

Albuterol, ipratropium bromide

Drug

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.

Other names: Albuterol, Atrovent

ipratropium bromide

Drug

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.

Other names: Atrovent

Primary outcomes

  1. Median Change in Asthma Score 2 Hours After Intervention

    Time frame: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator

    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.

  2. Mean Change in Asthma Score at 2 Hours

    Time frame: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator

    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 outcomes

  1. Number of Patients Hospitalized

    Time frame: within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo

    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.

  2. Change in Mean Heart Rate

    Time frame: From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

    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

  3. Mean Change in Respiratory Rate.

    Time frame: Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator

    Mean respiratory rate in breaths per minute before treatment minus respiratory rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator.

  4. Oxygen Saturation.

    Time frame: 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator

    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.

  5. Number of Subjects Remaining in the Severe Asthma Category

    Time frame: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

    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.

  6. Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category

    Time frame: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

    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.

  7. Number of Subjects Moving From the Severe Asthma to Mild Asthma Category

    Time frame: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

    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.

  8. Relapse / Readmission Numbers.

    Time frame: within 5 days of ED visit

    Participants admitted to the hospital within 5 days of the ED visit

  9. Number of Participants With Adverse Events (Non-serious).

    Time frame: within 30 days of the ED visit

  10. Serious Adverse Events

    Time frame: 0-5 days

    Serious Adverse Events

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 27, 2006
Registry last updated
Aug 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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