Asthma Clinical Trial
— AIMSOfficial title:
Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS)
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.
Status | Completed |
Enrollment | 238 |
Est. completion date | November 2006 |
Est. primary completion date | November 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Months to 59 Months |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | National Jewish Medical and Research Center | Denver | Colorado |
United States | Dept. of Health Evaluation Sciences, Penn State College of Medicine | Hershey | Pennsylvania |
United States | UCSD School of Medicine | LaJolla | California |
United States | University of Wisconsin - Madison | Madison | Wisconsin |
United States | Washington University School of Medicine Patient Oriented Research Unit | St. Louis | Missouri |
United States | University of Arizona, College of Medicine | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Bacharier LB, Phillips BR, Zeiger RS, Szefler SJ, Martinez FD, Lemanske RF Jr, Sorkness CA, Bloomberg GR, Morgan WJ, Paul IM, Guilbert T, Krawiec M, Covar R, Larsen G, Mellon M, Moss MH, Chinchilli VM, Taussig LM, Strunk RC; CARE Network. Episodic use of — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of episode-free days as determined by diary cards | Measured over 12-month follow-up period | Yes | |
Secondary | 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 | Yes | |
Secondary | 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 | Yes | |
Secondary | 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 | Yes | |
Secondary | Number of wheezing episodes | Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization | Yes | |
Secondary | Time to treatment failure | Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization | Yes | |
Secondary | 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 | Yes | |
Secondary | 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 | Yes | |
Secondary | Linear growth | Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization | No |
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