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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
238
Participants will receive inhaled corticosteroid for 7 days, at the first sign of RTI-associated symptoms.
Participants will receive leukotriene receptor antagonist for 7 days, at the first sign of RTI-associated symptoms.
All participants will receive inhaled albuterol treatments four times a day.
University of Arizona, College of Medicine
Tucson, Arizona, United States
UCSD School of Medicine
La Jolla, California, United States
National Jewish Medical and Research Center
Denver, Colorado, United States
Washington University School of Medicine Patient Oriented Research Unit
St Louis, Missouri, United States
Proportion of episode-free days as determined by diary cards
Time frame: Measured over 12-month follow-up period
Time to initiation of first course of oral corticosteroids
Time frame: 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
Time frame: 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
Time frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
Number of wheezing episodes
Time frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
Time to treatment failure
Time frame: 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
Time frame: 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
Time frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
Linear growth
Time frame: Measured at Weeks 2, 4, 10, 12, 18, 20, 26, 28, 34, 36, 42, 44, 50, and 52 after randomization
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Dept. of Health Evaluation Sciences, Penn State College of Medicine
Hershey, Pennsylvania, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States