Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS)

Inclusion Criteria:

• Recurrent episodes (at least two) of wheezing in the context of a RTI, at least one of which must be documented by a health care provider (parental report) over the 12 months prior to study entry, and of which one episode must have occurred within 6 months prior to study entry

• Either two episodes of '1,' OR two episodes of '2,' OR one episode of '1' AND one episode of '2,' defined by the following:

  1. Urgent care visit for acute wheezing (emergency department, urgent care center, or unscheduled primary care physician office visit), which required treatment with a bronchodilator, within 12 months prior to study entry
  2. Episode of wheezing within 12 months prior to study entry, which required treatment with oral corticosteroids not associated with a visit to a health care provider, urgent care center, emergency department, or hospital
• Immunizations are up to date, including varicella (unless the patient has already had clinical varicella)
• Willingness to provide informed consent by patient's parent or guardian

Exclusion Criteria:

• Use of more than six courses of systemic corticosteroids during the 12 months prior to study entry
• More than two hospitalizations for wheezing illnesses within 12 months prior to study entry
• Use of long-term controller medications for asthma (including inhaled corticosteroids, leukotriene modifiers, cromolyn/nedocromil, or theophylline) for 4 or more months (cumulative use) within 1 year prior to study entry
• Any use of long-term controller medications for asthma (including corticosteroids [inhaled or oral], leukotriene modifiers, cromolyn/nedocromil, or theophylline) within the 2 weeks prior to the enrollment visit
• Current treatment with antibiotics for diagnosed sinus disease
• Contraindication of use of systemic corticosteroids
• Prematurity (defined as birth before 36 weeks gestational age)
• Presence of lung disease other than asthma (e.g., cystic fibrosis and BPD)
• Presence of other significant medical illnesses (e.g., cardiac, liver, gastrointestinal, or endocrine disease) that would place the patient at increased risk
• Gastroesophageal reflux under medical therapy
• Immunodeficiency disorders
• History of respiratory failure requiring mechanical ventilation
• History of hypoxic seizure
• Inability to cooperate with nebulization therapy
• Inability to ingest the study drugs
• History of significant adverse reaction to any study medication ingredient
• Current participation, or participation in the month prior to study entry, in another investigational drug study
• Evidence that the family may be unreliable, nonadherent, or likely to move from the clinical center area before study completion
• Persistent symptomatic asthma, as defined as experiencing symptoms (i.e., nocturnal cough, daytime cough, wheezing, difficulty breathing, or symptoms interfering with activities) and/or requiring albuterol use on average 4 or more days per week in the 2-week observation period prior to the randomization visit
• The following scores, based on a 5-point scale with 5 representing very severe symptoms (measured at randomization visit): score equal to or greater than one for albuterol use, wheezing, difficulty breathing, nighttime cough, and asthma symptoms interfering with activities; score greater than 2 for daytime cough on an average of 4 or more days/week during the 2-week observation period
• Failure to complete diary cards at expected levels (at least 80% of days) during the observation period
• Use of long-term controller medications for asthma (e.g., corticosteroids [inhaled or oral], leukotriene modifiers, cromolyn/nedocromil, or theophylline) during the 2-week observation period