PEDIATRICS Vol. 114 No. 2 August 2004, pp. 544-545
EFFECTS OF BUDESONIDE INHALATION SUSPENSION, COMPARED WITH CROMOLYN SODIUM NEBULIZER SOLUTION, ON HEALTH STATUS AND CAREGIVER QUALITY OF LIFE IN CHILDHOOD ASTHMA
Christopher Randolph, MD
Waterbury, CT
Murphy KR, Fitzpatrick S, Cruz-Rivera M, et al. Pediatrics. 2003;112:e212–e219
 |
Purpose of the Study.
|
|---|
To compare the effects of 2 nebulized antiinflammatory asthma
medications on asthma control and caregiver quality of life.
|
Study Population.
|
|---|
Children 2 to 6 years of age, with mild/moderate persistent
asthma, were studied.
|
Methods.
|
|---|
This was a 52-week randomized trial in which the children received
either budesonide inhalation suspension (0.5 mg once or twice
daily) (
N = 168) or cromolyn sodium nebulizer solution (20 mg
4 times daily) (
N = 167) initially for 8 weeks, after which
the dosage was adjusted at the discretion of the investigator.
The Pediatric Asthma Caregiver’s Quality of Life Questionnaire,
Compliance/Caregiver Satisfaction Questionnaire, and Modified
Child Health Questionnaire-Parent Form 50 and Functional Status-II(R)
questionnaires were administered at baseline and at weeks 8,
28, and 52. At the conclusion of the study, global evaluations
of the simplicity of asthma management and child health care
status were obtained from caregivers and physicians.
|
Results.
|
|---|
Improvements from baseline values in domain-specific (activities
and emotional function) and total quality of life scores were
greater at each time point (weeks 8, 28, and 52) for caregivers
of patients treated with budesonide, compared with caregivers
of patients treated with cromolyn sodium. Only the budesonide
group met the criterion for a clinically important improvement
(
0.5-unit change) in all quality of life domains by week 8,
which was maintained at weeks 28 and 52. Budesonide resulted
in greater caregiver satisfaction, treatment convenience, ease
of use, and compliance, compared with cromolyn sodium. Therefore,
90.7% of caregivers in the budesonide group were completely
or very satisfied, compared with 53.4% in the cromolyn sodium
group. More than one-half (54.6%) of caregivers in the budesonide
group rated budesonide highly or very convenient, compared with
23% for cromolyn sodium; 77% rated budesonide extremely or very
easy to use, compared with 47% for cromolyn. Adherence with
daily medication regimens was reported for 76% of children in
the budesonide group, compared with 57% in the cromolyn sodium
group. Child health status showed improvements from baseline
values for both groups at weeks 8, 28, and 52. There was a trend
for these improvements to be superior in the budesonide group.
In addition, budesonide was superior to cromolyn sodium in caregiver
and physician global assessments.
|
Conclusions.
|
|---|
Budesonide inhalation suspension improved the quality of life
for caregivers of children with asthma. Caregivers of children
treated with budesonide reported significantly fewer limitations
in daily activities and emotional functioning, compared with
caregivers of children treated with cromolyn sodium nebulizer
solution. Children treated with budesonide inhalation suspension
and cromolyn sodium experienced improvements in health status.
Treatment with budesonide inhalation suspension resulted in
significantly lower mean rates of asthma exacerbations, significantly
longer times to first asthma exacerbation, significantly longer
times to first additional use of chronic asthma therapy, and
significant improvements in asthma symptom scores and breakthrough
medication use, compared with cromolyn sodium therapy. Safety
profiles were similar for the 2 treatment groups. Budesonide
inhalation suspension was associated with significantly greater
caregiver satisfaction, convenience, ease of use, and compliance,
compared with cromolyn sodium nebulizer solution.
|
Reviewer’s Comments.
|
|---|
This was a nice study but the results are certainly not surprising.
How many of us would have predicted that cromolyn would prove
superior to an inhaled corticosteroid?
PEDIATRICS (ISSN 1098-4275). ©2004 by the American Academy of Pediatrics
CiteULike 
Connotea 
Del.icio.us 
Digg 
Facebook 
Reddit 
Technorati 
Twitter What's this?
TOP
Purpose of the Study.
Study Population.
