Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS)
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February 2004-November 2006
Dataset(s) Last Updated
August 12, 2020
Clinical Trial URLs
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Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
To compare the effectiveness of a high dose of inhaled corticosteroids (ICS) plus an inhaled beta2-agonist (albuterol) or leukotriene receptor antagonist (LTRA) plus an inhaled beta2-agonist (albuterol) at the onset of respiratory tract illness (RTI)-associated symptoms among young children with recurrent severe wheezing.
Asthma is a condition that afflicts almost 9 million children in the United States each year. It is the leading cause of pediatric hospitalization and school absenteeism, and is characterized by symptoms of wheezing, coughing, and shortness of breath. Rates for wheezing-related emergency department visits and hospitalizations are highest among children under five years of age, reflecting not only the significant morbidity associated with these exacerbations, but also the difficulty in treating wheezing illness in a way that might prevent progression of illness severity. Better management strategies are needed to reduce severity and mortality. This study was developed to examine whether use of an ICS or LTRA were effective in reducing episode-free days (EFDs) over a 12- month period in preschoolers with intermittent wheezing.
351 pediatric participants were enrolled in the study. Of these, 238 were randomized, and 220 completed the trial or reached criteria for treatment failure.
Participants were eligible for enrollment if they were aged 12-59 months and had experienced at least 2 episodes of wheezing in the context of a respiratory tract infection (RTI) within the past year, with one episode occurring 6 months prior to enrollment and at least one episode documented by a health care provider.
A patient became eligible for randomization following a 2-week run-in period during which parents completed diary cards twice daily. Children were excluded if: parents completed diary cards <80% of the 2 weeks, if asthma medication were used, or if the score card indicated symptoms of greater frequency.
Participants were considered excluded for any of the following conditions or concerns: > 6 courses of oral corticosteroids; >2 hospitalizations for wheezing; or use of asthma-controlled medications for >4 months cumulative or within the two weeks preceding enrollment. Other exclusion criteria included: <36-week gestational age; presence of other significant medical conditions; gastroesophageal reflux under medical therapy; current antibiotic use for sinusitis; or history of life-threatening wheezing episode.
After completing the 2-week run-in period, participants were randomly assigned to 3 parallel treatment groups:
- Budesonide group: budesonide inhalation suspension (1mg) twice daily and placebo LTRA once daily
- Montelukast group: montelukast (4mg) daily and placebo ICS twice daily
- Conventional therapy group: placebo ICS twice daily and placebo LTRA one daily
All participants received albuterol treatments 4 times daily during wake hours for the first 48 hours followed by albuterol use as needed. Oral corticosteroids were available for participants at home and were started based on a specific treatment algorithm.
Individualized timing for starting the treatment group medications was derived according to an education protocol designed and evaluated in a prior pilot study. Parents were instructed to begin a 7-day course of treatment at onset of the individualized set of symptoms identified as their child’s starting point. The same treatment intervention was used in any subsequent illness characterized by RTI-associated wheezing.
During the study period, clinic visits were performed at 4 weeks post-randomization and then every 8 weeks thereafter. Telephone visits were performed at 2 weeks post-randomization and then 4 weeks after each clinic visit.
The primary outcome was the proportion of episode-free days (EFDs) as recorded on diary cards twice daily for the 12-month trial. An EFD was defined as a day during which the participant was free from: cough, wheeze, trouble breathing, asthma-associated interference with daily activities or sleep, unscheduled contact with a health care provider due to wheezing, and use of asthma-related non-study medications.
The CARE-AIMS study did not show a statistically significant response in preschool children with moderate-to-severe intermittent wheezing. Although the episodic use of budesonide or montelukast did not increase the proportion of episode-free days, it was successful in decreasing symptom severity during acute respiratory tract illnesses.
Bacharier LB, Phillips BR, Zeiger RS, et al. Episodic use of an inhaled corticosteroid or leukotriene receptor antagonist in preschool children with moderate-to-severe intermittent wheezing. J Allergy Clin Immunol. 2008;122(6):1127-1135.e8. doi:10.1016/j.jaci.2008.09.029
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