Data from Clinical Therapeutics - Curated by EPG Health - Date available 01 June 2002


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1 June 2002

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Background: Because the symptoms of seasonal allergic rhinitis are readily recognizable, many individuals self-medicate with nonprescription agents. The mast-cell stabilizer cromolyn sodium is available for over-the-counter (OTC) use in the prevention and treatment of allergic rhinitis.

Objective: The goal of the study was to evaluate the efficacy of cromolyn sodium 4% nasal solution for the treatment of allergic rhinitis in self-selected patients in a nonprescription setting. A secondary objective was to determine whether the instructions and warnings in the OTC labeling provide adequate information for safe and proper OTC use.

Methods: This 2-week, multicenter study had a randomized, double-blind, placebo-controlled, parallel-group design. Advertisements were used to identify allergy sufferers who used OTC products but had not used OTC allergy medications within 48 hours of study entry and did not require prescription medications to control allergy symptoms. Enrolled patients were randomized to receive either cromolyn sodium 4% nasal solution in a metered-spray bottle containing 200 doses or an identical-appearing placebo. They were instructed to follow the directions for use on the label: that is, to administer 1 spray in each nostril every 4 to 6 hours, no more than 6 times per day, for the prevention or relief of symptoms. Daily use of study drug and concomitant medications was recorded in patient diaries. Patients also rated symptom severity, symptom relief, medication efficacy, and helpfulness of the label instructions. Relief of overall and individual rhinitis symptoms was assessed at the end of weeks 1 and 2.

Results: The intent-to-treat population consisted of 1150 patients (580 cromolyn sodium, 570 placebo). Cromolyn sodium provided greater relief than placebo on all efficacy measures and was statistically significantly more effective than placebo in controlling allergy symptoms (P = 0.02), providing overall symptom relief (P = 0.02), and relieving sneezing (P = 0.01) and nasal congestion (P = 0.03). The instructions for use were rated helpful to extremely helpful by >92% of patients, although only approximately 48% of patients used the drug according to the label instructions. The most common adverse events in both groups were headache and rhinitis, and there was no significant difference in the rates of such events between groups.

Conclusion: In this study, cromolyn sodium 4% nasal solution was well tolerated and effective, suggesting that it is suitable for OTC use in the treatment of seasonal allergic rhinitis.

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