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Clinical Trial
. 2004 Nov;93(5):452-9.
doi: 10.1016/S1081-1206(10)61412-3.

Addition of ibuprofen to pseudoephedrine and chlorpheniramine in the treatment of seasonal allergic rhinitis

Eli O Meltzer  1 , Gary D Berman, Jonathan Corren, Andrew J Pedinoff, Geraldine Doyle, Joel A Waksman, Paul Butkerait, Stephen A Cooper, Roger G Berlin, Suman Wason
Affiliations
Clinical Trial

Addition of ibuprofen to pseudoephedrine and chlorpheniramine in the treatment of seasonal allergic rhinitis

Eli O Meltzer et al. Ann Allergy Asthma Immunol. 2004 Nov.

Abstract

Background: Patients with seasonal allergic rhinitis experience many nasal and concomitant nonnasal symptoms. Many patients also experience headaches and facial pain, pressure, or discomfort. Standard over-the-counter therapy with antihistamines and nasal decongestants often does not completely relieve all symptoms associated with allergic rhinitis.

Objective: To establish the contribution of ibuprofen when used with pseudoephedrine and chlorpheniramine, a standard over-the-counter regimen, to relieve the symptoms of seasonal allergic rhinitis.

Methods: In this 7-day, multicenter, randomized, placebo-controlled, double-blind, double-dummy, parallel-group trial, qualified subjects were randomly assigned to 1 of 4 treatment groups that received combined ibuprofen/pseudoephedrine/chlorpheniramine (200/30/2 mg or 400/60/4 mg), combined pseudoephedrine/chlorpheniramine (30/2 mg), or placebo. Therapy began when the subject experienced a minimum of moderate allergy-associated pain, and it continued 3 times a day for 7 consecutive days.

Results: Mean pain intensity reduction in both ibuprofen/pseudoephedrine/chlorpheniramine treatment groups was 40% greater than in the placebo group and 33% greater than in the pseudoephedrine/chlorpheniramine treatment group (P < .001). Mean changes from baseline in total and nonpain symptom scores for both ibuprofen/pseudoephedrine/chlorpheniramine doses were significantly greater than for placebo (P < .001) and pseudoephedrine/chlorpheniramine (P < .001-.05) but were not different from each other. Ibuprofen enhanced the chlorpheniramine and pseudoephedrine effects, resulting in incremental 33% to 34% pain relief and 17% to 22% allergy symptom relief compared with pseudoephedrine/chlorpheniramine.

Conclusions: In both doses of the triple combination, ibuprofen added to the effects of chlorpheniramine and pseudoephedrine, resulting in superior relief of pain and all nonpain allergy symptoms compared with pseudoephedrine/chlorpheniramine treatment. Furthermore, the superior efficacy of the lower dose of the triple combination allowed for a decrease in the incidence of adverse effects.

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