PEDIATRICS Vol. 114 No. 2 August 2004, pp. 525
EFFICACY OF THE TOPICAL NASAL STEROID BUDESONIDE ON IMPROVING SLEEP AND DAYTIME SOMNOLENCE IN PATIENTS WITH PERENNIAL ALLERGIC RHINITIS
Tamara T. Perry, MD,
Robert A. Wood, MD
Baltimore, MD
Hughes K, Glass C, Ripchinski M, et al. Allergy. 2003;58:380–385
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Purpose of the Study.
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To determine the efficacy of topical nasal corticosteroids in
the improvement of sleep and daytime somnolence among patients
with perennial allergic rhinitis (PAR).
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Study Population.
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Twenty-two subjects (18–65 years of age) with positive
skin test responses to perennial allergens but not seasonal
allergens were enrolled in the study.
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Methods.
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The study was a double-blind, placebo-controlled, crossover
study that incorporated Balaam’s design. Patients were
randomized to 1 of 4 treatment groups, ie, active-placebo, placebo-active,
active-active, or placebo-placebo. Patients received 2 sprays
of the active medication (budesonide, 128 µg/day) or placebo
once daily for 4 weeks. After a 1-week washout period, patients
crossed over to the second arm of the study, according to the
randomization sequence. Patients completed daily diaries, commenting
on nasal symptoms, sleep, daytime somnolence, quality of sleep,
and medication response. At weeks 1, 4, 5, and 8, patients completed
subjective questionnaires during clinic visits, to assess quality
of life, somnolence, and fatigue.
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Results.
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Analyses of data obtained from the daily diaries showed that
patients receiving active medication demonstrated significant
improvements in daytime fatigue, somnolence, sleep problems,
and quality of life, compared with those receiving placebo.
There was no significant difference in nasal congestion or other
symptoms of rhinitis between the treatment groups. Patients
receiving active medication were significantly less likely to
fall asleep during normal daily activities, but there was no
difference in the numbers of hours of sleep or nighttime arousals.
Those in the active group also had significantly more restorative
sleep and reported feeling more refreshed, compared with those
receiving placebo.
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Conclusions.
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Patients with PAR who were receiving the topical nasal corticosteroid
budesonide demonstrated significant improvements in daytime
somnolence, fatigue, and sleep problems.
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Reviewers’ Comments.
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Patients with allergic rhinitis frequently complain of nocturnal
symptoms, such as nasal congestion and rhinorrhea, that interfere
with sleep, and previous studies showed that patients with allergic
rhinitis have significantly more difficulty with daytime somnolence
and sleep problems. This study offers encouraging data on the
usefulness of topically applied nasal corticosteroids in improving
sleep-related problems among patients with PAR and provides
more evidence supporting the recommendation of topically applied
nasal corticosteroids as the primary treatment for allergic
rhinitis.
PEDIATRICS (ISSN 1098-4275). ©2004 by the American Academy of Pediatrics
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Purpose of the Study.
Study Population.
