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

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the effectiveness of initiating a high-dose inhaled corticosteroid (ICS) or a leukotriene receptor antagonist (LTRA) in addition to an inhaled beta2-agonist (albuterol) at the onset of respiratory tract illness (RTI)-associated symptoms in increasing episode-free days among young children with recurrent severe wheezing.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Albuterol; Budesonide; Leukotriene Antagonists; Montelukast

Criteria

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