Standard treatment for seasonal allergic rhinitis consists of either an inhaled corticosteroid or a second-generation nonsedating antihistamine. Ratner and colleagues conducted a double-blind, placebo-controlled trial to evaluate whether concurrent administration of these medications provides any added benefit compared with monotherapy.
Patients who were at least 12 years old were included in the study if they had a positive skin-test reaction to mountain cedar, had the nasal mucosal appearance typical of seasonal allergic rhinitis and had a history of moderate to severe symptoms. Patients who had recently received antihistamines, corticosteroids or nasal decongestants were excluded from participation. Study subjects began a one-week to one-month run-in period and recorded their symptoms daily for the duration of the study. Patients were randomly assigned to receive one of four regimens: (1) two daily 50-μg sprays per nostril of fluticasone propionate aqueous nasal spray plus a placebo capsule; (2) a 10-mg loratadine capsule plus placebo nasal spray; (3) both treatment medications; or (4) a placebo spray and a placebo capsule. Use of other medications that could affect rhinitis symptoms was not permitted. Nasal symptoms and adverse events were recorded throughout the study, and each patient was examined for the development of nasal or oropharyngeal candidiasis. The patients also completed a disease-specific quality-of-life questionnaire.
A total of 569 patients completed the study. By the seventh day, the physicians rated nasal symptoms in the fluticasone nasal spray groups as significantly better than symptoms in the other groups. At 14 days, the treatment groups continued to have fewer symptoms than the placebo group.
Symptoms were most improved in the groups taking fluticasone. The patients in the combination therapy group rated their nasal symptoms (specifically, nasal blockage, nasal discharge and sneezing) most improved. The fluticasone and fluticasone-loratadine treatment regimens were more effective than the loratadine monotherapy regimen. Adverse effects were rare.
The authors conclude that patients with seasonal allergic rhinitis may be treated effectively with a 200-μg daily dosage of fluticasone propionate aqueous nasal spray. The addition of loratadine does not significantly benefit these patients.