Hughes K, Glass C, Ripchinski M, et al. Allergy. 2003;58:380–385
Purpose of the Study.
To determine the efficacy of topical nasal corticosteroids in the improvement of sleep and daytime somnolence among patients with perennial allergic rhinitis (PAR).
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.
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.
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.
Patients with PAR who were receiving the topical nasal corticosteroid budesonide demonstrated significant improvements in daytime somnolence, fatigue, and sleep problems.
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.