The objective of this study is to determine whether, in children receiving low-dose inhaled corticosteroids (ICS), quintupling the dose of inhaled corticosteroids at the onset of symptoms previously associated with upper respiratory illnesses and subsequent asthma exacerbations reduces the rate of severe asthma exacerbations treated with oral corticosteroids.
The study design is a double-blind, parallel-group trial, including a total of 250 participants, ages 5-11 years, with a diagnosis of asthma and a history of at least 1 asthma exacerbation treated with oral corticosteroids in the prior year. All participants will be treated for 48 weeks with open-label fluticasone 44 mcg 2 puffs twice daily. During the 48-week treatment period, participants will receive randomized blinded therapy for 7 days each time they enter the "yellow zone" (at the onset of symptoms previously associated with upper respiratory illnesses and subsequent asthma exacerbations). Yellow zone therapy will be fluticasone 44 or 220 mcg 2 puffs twice daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
254
Fluticasone is an inhaled corticosteroid
Fluticasone is an inhaled corticosteroid
University of Arizona College of Medicine
Tucson, Arizona, United States
Children's Hospital & Research Center Oakland
Oakland, California, United States
Asthma Exacerbations
The primary outcome is the rate of severe asthma exacerbations treated with oral corticosteroids during the 48 week treatment period.
Time frame: end of 48 week treatment period
Yellow Zone Asthma Symptoms
Study participants completed a daily symptom diary. They scored the following diary elements on a scale from 0-3 (none-severe): Cough, Wheeze, Trouble Breathing, Interference With Activities. A combined score was calculated as the sum of the 4 elements and ranged from 0 to 12. The study intervention was based on yellow-zones as noted in the Study Description. This outcome was based on diary data including 21 days, beginning 7 days prior to the onset of the yellow-zone intervention and ending 14 days after the onset of the intervention. The total symptom burden outcome was defined as the sum of the combined score on each diary day and ranged from 0 to 252 (max combined score of 12 per day multiplied by 21 days). A score of zero would indicate no symptoms over the entire 21 days. A score of 252 would indicate severe cough, wheeze, shortness of breath, and interference with activities on all of the 21 days.
Time frame: end of 48 week treatment period
Yellow Zone Albuterol Use
Use of albuterol rescue medication during 7-day yellow zone episodes.
Time frame: end of 48 week treatment period
Unscheduled Emergency Department (ED) or Urgent Care Visits for Asthma
Rate of emergency department (ED) or urgent care visits for asthma during the 48 week treatment period.
Time frame: end of 48 week treatment period
Number of Participants Hospitalized for Asthma
Number of participants hospitalized for asthma during the 48 week treatment period.
Time frame: end of 48 week treatment period
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