Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS) (AIMS)
Asthma, Lung Diseases
About this trial
This is an interventional treatment trial for Asthma focused on measuring Wheezing, Respiratory Tract Illness
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: 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 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
Sites / Locations
- University of Arizona, College of Medicine
- UCSD School of Medicine
- National Jewish Medical and Research Center
- Washington University School of Medicine Patient Oriented Research Unit
- Dept. of Health Evaluation Sciences, Penn State College of Medicine
- University of Wisconsin - Madison
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
1
2
3
Active ICS plus placebo LTRA plus albuterol inhalation treatments four times daily
Active LTRA plus placebo ICS plus albuterol inhalation treatment four times daily
Placebo ICS plus placebo LTRA plus albuterol inhalation treatments four times daily