childhood asthma research and education (care) network trial - acute intervention management strategies (aims)

Conditions: Asthma; Lung Diseases

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.

acute intervention management strategies (aims) is a randomized, double-blind, double-dummy, placebo-controlled parallel comparison study that will compare the effectiveness of three treatments, when given at the onset of rti-associated symptoms, in increasing the proportion of symptom-free days over the entire treatment period of the 5- to 9-month study. there will be a 2-week period to qualify and characterize participants, who at that time will have no lower respiratory tract symptoms other than mild cough. a total of 244 participants will be randomized to one of three treatment groups and followed for the remainder of the fall-winter-early spring season. participants will receive one of the following treatment regimens for 7 days, at the first sign of rti-associated symptoms: 1) active ics plus placebo ltra plus albuterol inhalation treatments four times daily; 2) active ltra plus placebo ics plus albuterol inhalation treatment four times daily; or 3) placebo ics plus placebo ltra plus albuterol inhalation treatments four times daily.

Eligibility 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

Keywords: wheezing respiratory tract illness