Nasal congestion secondary to allergic rhinitis as a cause of sleep disturbance and daytime fatigue and the response to topical nasal corticosteroids☆,☆☆,★,★★
Section snippets
Methods
The investigation was designed as a double-blind, placebo-controlled, crossover study and incorporated Balaam's design, which uses the sequences AP (active-placebo), PA (placebo-active), AA (active-active), and PP (placebo-placebo). In a crossover design each subject serves as his or her own control. Therefore the estimated treatment differences tend to have less variability than that observed in a parallel design. Smaller variability leads to a smaller sample size. Also, the
Results
Nineteen of the 20 patients who entered the study completed the protocol. Two patients who were randomized to active therapy first and later crossed over to placebo were unable to continue receiving the placebo because of the severity of their symptoms. One patient left the study, and the other was continued but switched to open-label therapy. The latter patient's data were analyzed in the group to which he was randomized (placebo) because the blind was not removed until completion of the
Discussion
Allergic rhinitis is the most common allergic disease in the United States, with an incidence of approximately 15% to 20% in North America.18 Allergic rhinitis is characterized by an IgE-mediated nasal response to allergens resulting in activation of mast cells, release of chemical mediators, and the influx of inflammatory cells, especially eosinophils. It is this inflammation that gives rise to the congestion that frequently complicates perennial AR. Somewhere between 40% and 65% of patients
Acknowledgements
We thank Angela Hamilton for her assistance in preparation of this manuscript.
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From athe Allergy Clinic, Division of Medicine, Section of Pulmonary, Allergy, and Critical Care; bthe College of Medicine; and cthe Department of Health Evaluation Sciences, Penn State University, Hershey; and dMedical Services, Denver Veterans Affairs Medical Center, Denver.
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Supported by the Pulmonary Research Fund at Penn State University.
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Reprint requests: Timothy Craig, DO, Department of Medicine, Section Pulmonary, Allergy, Critical Care, 500 University Drive, Hershey, PA 17033.
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