Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS)
Overview
- Phase
- Not Applicable
- Intervention
- Inhaled Corticosteroid (Budesonide)
- Conditions
- Asthma
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Enrollment
- 238
- Locations
- 6
- Primary Endpoint
- Proportion of episode-free days as determined by diary cards
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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 the onset of respiratory tract illness (RTI)-associated symptoms in increasing episode-free days among young children with recurrent severe wheezing.
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 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.
Investigators
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
Arms & Interventions
1
Active ICS plus placebo LTRA plus albuterol inhalation treatments four times daily
Intervention: Inhaled Corticosteroid (Budesonide)
1
Active ICS plus placebo LTRA plus albuterol inhalation treatments four times daily
Intervention: Inhaled Albuterol
2
Active LTRA plus placebo ICS plus albuterol inhalation treatment four times daily
Intervention: Leukotriene Receptor Antagonist (Montelukast Sodium)
2
Active LTRA plus placebo ICS plus albuterol inhalation treatment four times daily
Intervention: Inhaled Albuterol
3
Placebo ICS plus placebo LTRA plus albuterol inhalation treatments four times daily
Intervention: Inhaled Albuterol
Outcomes
Primary Outcomes
Proportion of episode-free days as determined by diary cards
Time Frame: Measured over 12-month follow-up period
Secondary Outcomes
- Number of wheezing episodes(Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization)
- Time to treatment failure(Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization)
- Measures of patient and family morbidity(Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization)
- Time to initiation of first course of oral corticosteroids(Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization)
- Total number of courses of oral corticosteroids(Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization)
- Duration and severity of lower respiratory tract symptoms(Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization)
- Number of unscheduled visits for acute wheezing episodes(Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization)
- Linear growth(Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization)