Budesonide and terfenadine, separately and in combination, in the treatment of hay fever.

Background: While hay fever is a very common experience, its treatment in primary care setting has been little reported in controlled studies.

Objective: This study sought to evaluate the patient's assessment of efficacy of an intranasal steroid spray (budesonide) alone or in combination with an antihistamine (terfenadine) against terfenadine alone or placebo alone.

Methods: A double-blind parallel group, placebo-controlled trial design was used, comparing the four groups. Each group used an active or placebo spray and active or placebo tablets. Symptom scores were recorded daily in diaries over a 21-day period.

Results: Overall assessment of efficacy by the 106 patients was significantly greater (P < .05) for budesonide versus terfenadine or placebo alone. There was a 40% placebo response. Budesonide was more effective than terfenadine for all individual symptom scores, particularly nasal blockage, against which terfenadine was ineffective. Adverse effects were mild and transient for all groups.

Conclusions: Budesonide alone is a highly effective treatment for hay fever with few side effects.