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Ibuprofen Added to Decongestant + Antihistamine Helps Relieve Seasonal Allergic Rhinitis: Presented at ACAAI

By Paula Moyer

NEW ORLEANS, LA -- November 27, 2003 -- Adding low-dose ibuprofen to the conventional allergy-relief cocktail of chlorpheniramine and pseudoephedrine enhances relief from seasonal allergic rhinitis, according to findings presented here at the American College of Allergy, Asthma, and Immunology Annual Meeting, November 6-12, 2003.

The addition of ibuprofen also reduces the risk of drowsiness associated with chlorpheniramine, because the triple combination allows for sufficient relief of symptoms at a lower dose of chlorpheniramine than is typically used, the investigators reported.

"Ibuprofen reduces allergy-associated pain, and adds to the effects of chlorpheniramine and pseudoephedrine for non-pain symptoms," stated lead investigator Eli O. Meltzer, MD, co-director, Allergy and Asthma Medical Group and Research Center, San Diego, California, United States. "The triple combination is well tolerated," he added. This treatment is the first over-the-counter product to combine a nonsteroidal anti-inflammatory drug (NSAID), an antihistamine, and a decongestant for the relief of seasonal allergic rhinitis, Dr. Meltzer noted.

The research team wanted to see if the addition of ibuprofen would be beneficial, as people who live with this condition also have headaches, facial pain, or both, and because NSAIDs not only reduce discomfort, but also are known to relieve the nasal symptoms associated with colds.

In this 7-day trial, the investigators randomised patients to placebo or to treatment in a double blind, double-dummy, parallel-group fashion. The participants consisted of patients who had at least a 2-year history of seasonal allergic rhinitis.

In 1 group, subjects received a triple combination consisting of ibuprofen, pseudoephedrine, and chlorpheniramine (n = 265). In the first arm of the triple-combination group, subjects received 200 mg ibuprofen, 30 mg pseudoephedrine, and 2 mg of chlorpheniramine, while in the second arm subjects received 400 mg of ibuprofen, 60 mg of pseudoephedrine, and 4 mg of chlorpheniramine. A second group of patients received pseudoephedrine (30 mg) and chlorpheniramine (2 mg) without ibuprofen (n = 266). The third group received a placebo (n = 257).

The investigators asked patients to assess 6 allergy-associated symptoms, including pain, on a 4-point severity score scale, with assessments made every other day. The investigators recorded pain intensity at baseline and at 2 and 3 hours after the first dose.

In both arms of group 1, which received the ibuprofen-pseudoephedrine-chlorpheniramine combination, pain was lessened 40% more than in the placebo group, and 33% more than in the pseudoephedrine-chlorpheniramine treatment group (P < .001). Similarly, the average change from baseline regarding non-pain allergy symptom scores for both doses of the triple combination was significantly greater than placebo (P < .001). For these symptoms, both of the triple-combination arms and the pseudoephedrine group differed significantly from placebo (P < .05 or P < .001, with variances by symptom), but had similar results regarding symptoms.

When ibuprofen was added to chlorpheniramine and pseudoephedrine, the investigators found an incremental increase in pain relief that ranged from 33% to 34%. The incremental increases in other allergy symptoms ranged from 19% to 22% compared to the conventional combination.

Other than effects that had an impact on the central nervous system (CNS), the active treatment groups' adverse-event profiles were similar to placebo, the investigators reported. They found that the higher dose of the triple combination was associated with more CNS-related adverse effects compared to the low-dose combination.


[Study Title: Low-Dose Ibuprofen Augments the Effects of Pseudoephedrine and Chlorpheniramine in the Treatment of Seasonal Allergic Rhinitis. Abstract P96]

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