Clinical and antiinflammatory effects of intranasal budesonide aqueous pump spray in the treatment of perennial allergic rhinitis.

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.

• Authors: E O Meltzer
• Journal: Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology (Ann Allergy Asthma Immunol) Vol. 81 Issue 2 Pg. 128-34 (Aug 1998) ISSN: 1081-1206 [Print] United States
• PMID: 9723557 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents
• Water
• Budesonide

Topics

• Administration, Intranasal
• Adolescent
• Adult
• Anti-Inflammatory Agents (adverse effects, pharmacology, therapeutic use)
• Budesonide (administration & dosage, adverse effects, therapeutic use)
• Child
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Humans
• Male
• Nasal Mucosa (drug effects, pathology)
• Quality of Life
• Respiratory Tract Infections (chemically induced)
• Rhinitis, Allergic, Perennial (drug therapy, pathology)
• Treatment Outcome
• Water