TILARIN IN COMBINATION WITH ASTEMIZOLE

This multicentre double-blind, placebo controlled study had a practica l objective, based on the expectation that many patients with seasonal allergic rhinitis will be prescribed oral antihistamine monotherapy b y their primary care physician, whereas allergy specialists are more l ikely to prescribe combination therapy including antiinflammatories. T he specific question was, 'Will the addition of nedocromil sodium 1% n asal spray to astemizole tablets improve control of symptoms of season al allergic rhinitis induced by ragweed pollen, as compared to astemiz ole therapy alone?:. Following a one-week baseline, planned to coincid e with the start of the local ragweed pollen season? patients (aged 12 -64) were randomly assigned to four weeks' double-blind test treatment with either nedocromil sodium 1% nasal spray four times daily (QID)+a stemizole (n=146) or placebo nasal spray+astemizole (n=148) or double- dummy (nasal spray+capsules) placebo (n=71). Patient diary cards were kept throughout the five weeks, and clinic visits were made before and after baseline and after one and four weeks' treatment. During the 10 -day peak pollen period, the diary card rhinitis symptom summary score (0-4 severity scale) was significantly reduced in patients receiving either astemizole alone (p<0.001) or the combination therapy (p<0.001) as compared with placebo. Direct comparison of the active treatments further showed that symptoms were significantly less severe (p<0.01) w ith the combined therapy than with astemizole alone, and this despite significantly greater reliance on permitted rescue medications (p<0.05 for pseudoephedrine usage) in the astemizole group. Clinical assessme nts of rhinitis made during the peak pollen visit, after the first wee k of test treatment, were also significantly (p<0.05-p<0.01) in favour of combined therapy with nedocromil sodium 1% nasal spray+astemizole rather than astemizole alone, and at the same time this preference was confirmed by physician (p=0.011) and patient (p=0.003) opinions of sy mptom control. In conclusion, this antiinflammatory+antihistamine trea tment proved superior to antihistamine alone for effective management of allergic rhinitis. The combined therapy worked quickly and was well -tolerated, with no serious adverse events or untoward effects on bloo d or urine variables.