Status:
COMPLETED
Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS)
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Lung Diseases
Eligibility:
All Genders
12-59 years
Phase:
NA
Brief 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 th...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT00319488
Start Date
February 1 2004
End Date
November 1 2006
Last Update
July 29 2016
Active Locations (6)
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1
University of Arizona, College of Medicine
Tucson, Arizona, United States, 85724
2
UCSD School of Medicine
La Jolla, California, United States, 92093
3
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
4
Washington University School of Medicine Patient Oriented Research Unit
St Louis, Missouri, United States, 63110