Background: Antihistamines have been shown to be effective in patients
with allergic asthma, but their role in chronic and more severe asthm
a is uncertain. Objectives: To evaluate whether loratadine, a selectiv
e H-1 receptor antagonist, given as sn adjunct to standard asthma medi
cation would have any effect in patients with moderate-to-severe asthm
a. Methods: Thirty-five patients with moderate-to-severe asthma, most
receiving inhaled steroids, were enrolled in this double-blind crossov
er study. In addition to their maintenance therapy patients received e
ither loratadine, 20 mg once daily, or placebo for 4 weeks before cros
sing over to the other preparation for a further 4 weeks. Variables of
efficacy were daily and nocturnal respiratory symptoms, lung function
(PEF, FEV(1), FVC), and bronchodilator use. Results: Three subjects w
ere withdrawn from the study because of deteriorating asthma. There wa
s a trend in favor of loratadine treatment with regard to global asses
sment of drug efficacy but the difference was not statistically signif
icant. There was no objective improvement in asthma control comparing
loratadine with placebo but if each treatment week were compared with
the run-in period, PEF was significantly (P<.01) improved during the i
nitial phase of loratadine treatment. This effect gradually decreased
with time, suggesting tolerance to any bronchodilatory effect of the a
ntihistamine. Conclusion: Loratadine, given as an adjunct to standard
asthma therapy, has little if any role to play in the treatment of mod
erate-to-severe asthma.