CETIRIZINE IN PATIENTS WITH SEASONAL RHINITIS AND CONCOMITANT ASTHMA - PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL

Objective: This study explored the safety and efficacy of cetirizine for treatment of allergic rhinitis and asthma. Methods: Daily treatment for 6 weeks with cetirizine 10 mg (93 patients) was compared with placebo treatment(93 patients) in a randomized, double-blind parallel study of patients with allergic rhinitis and asthma. This multicenter study was started just-before onset of the fall pollen season. Rhinitis and asthma symptoms were assessed twice daily; spirometry was performed weekly. Results: Placebo-treated patients experienced a worsening of rhinitis symptoms from baseline throughout the study, whereas cetirizine-treated patients had a significant improvement in rhinitis symptoms at week I, which was maintained after onset of the pollen season. Asthma symptoms in the cetirizine group improved from baseline at week 1; symptoms were significantly better than in the placebo group for 5 of 6 weeks of the study. Pulmonary function did not worsen in patients taking cetirizine or placebo; there were no differences between treatments as determined by spirometry. Albuterol use was less frequent in the cetirizine-treated patients for every week of the study but differences did not reach significance. Pseudoephedrine use was similar in both groups. More cetirizine-treated patients (90%) completed the trial than did placebo-treated patients (74%). Both treatments were well tolerated. Conclusion: Cetirizine 10 mg daily is safe;and effective in relieving both upper and lower respiratory tract symptoms in patients with seasonal allergic rhinitis and concomitant asthma.