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  • Title: Clinical and antiinflammatory effects of intranasal budesonide aqueous pump spray in the treatment of perennial allergic rhinitis.
    Author: Meltzer EO.
    Journal: Ann Allergy Asthma Immunol; 1998 Aug; 81(2):128-34. PubMed ID: 9723557.
    Abstract:
    BACKGROUND: Intranasal corticosteroids are among the most effective treatments for perennial allergic rhinitis (PAR). Some individuals unable to tolerate aerosols may prefer an aqueous nasal spray. OBJECTIVE: To determine the efficacy, safety, and antiinflammatory effects of an intranasal aqueous pump spray formulation of budesonide. METHODS: Four hundred seventy-eight patients [257 adults, 221 children (6 to 17 years)] with PAR were randomized to budesonide aqueous pump spray (Rhinocort Aqua) 32, 64, 128, or 256 microg, or placebo once daily for 6 weeks. Patients recorded nasal/ocular symptom severity daily. Nasal cytology was evaluated at baseline and end of treatment. The study was powered only to evaluate the overall population for significance. RESULTS: Following 6 weeks of treatment, significant differences from baseline in nasal index score (NIS)--sum of blocked nose, runny nose, and sneezing scores--were observed in the 32-, 64-, and 256-microg aqueous budesonide groups compared with placebo (P < or = .031). No dose response was found for changes in NIS. Significant reductions from baseline NIS were observed with 256-microg aqueous budesonide compared with placebo in the first 24 hours following treatment (P = .004). Aqueous budesonide also significantly reduced individual nasal symptoms in two or more of the active treatment groups (P < or = .035). Patients' overall treatment efficacy assessments showed significantly greater symptom control with aqueous budesonide (P < or = .006), and overall quality of life improved. Significantly greater decreases in eosinophils and basophils were found in aqueous budesonide-treated groups (P < or = .007). The frequency of adverse events was similar among all treatments. CONCLUSIONS: Once daily aqueous budesonide is well tolerated and effective in relieving nasal symptoms and inflammation associated with PAR.
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