Effect of azelastine on the seasonal increase in non‐specific bronchial responsiveness to methacholine in pollen allergic patients. A randomized, double‐blind placebo‐controlled, crossover study

Abstract

Azelastine, a phthalazinone derivative, is a new potent, long acting, orally active anti-allergic compound with particularly strong H1-histamine receptor antagonistic effects which has been proven to possess in vitro and in vivo a number of anti-inflammatory properties. The aim of the present study was to investigate whether azelastine would be able to prevent and/or reverse the seasonal increase in non-specific bronchial responsiveness to methacholine in pollen allergic patients. Twelve atopic patients (5 males, mean age 31 years), skin positive exclusively to grass and/or Parietaria pollen extract, with rhinitis and mild asthma occurring in the spring for at least two years previously, were studied. After a 2 week run-in period, oral azelastine, 4 mg twice daily, or placebo, was given for 2 weeks from the start of the pollen season, according to a randomized, double-blind design. After 2 weeks, the treatments were crossed over. During both the run-in and study periods, patients recorded rhinitis and asthma symptoms, additional antihistamine and bronchodilator drugs taken and peak expiratory flow measurements. A methacholine inhalation test was carried out on four occasions in each patient: before the run-in period, before the start of the treatment, and at the end of the two 2 week treatment periods. Azelastine significantly reduced rhinitis symptoms and the need for antihistamine drugs, whereas asthmatic symptoms, use of bronchodilator drugs, peak flow recordings and bronchial responsiveness to methacholine were unaffected by the treatment. Compliance level and adverse side-effects were not significantly different between active treatment and placebo. In the final subjective evaluation of the two treatments, eight out of 12 patients preferred azelastine.(ABSTRACT TRUNCATED AT 250 WORDS)

Is there a place for antihistamines in the treatment of perennial asthma?

“…At the same time, the use of bronchodilators was reduced by 40%. Azelastine (4 mg twice daily) reduced nasal but not bronchial symptoms and did not reduce the use of bronchodilators nor did it protect against an increase in bronchial methacholine sensitivity during the pollen season (21). Cetirizine (10 mg twice daily) protected better than terfenadine (60 mg twice daily) against grass pollen-induced asthma and nasal blockage in 43 grass pollen-allergic subjects, 12-74 years of age (22).…”

Asthma and anaphylaxis: a relevant model for chronic disease? An historical analysis of directions in asthma research

“…While corticosteroids inhibit the late response [67] so do theophyllines [80], high doses of /3-agonists [81], long-acting /3-agonists [9], sodium cromoglycate [67], nedocromil sodium [82], H, antihistamines [83] and a leukotriene receptor antagonist [84], Where comparative studies have been made, the effect of corticosteroid and cromoglycate pretreatment are indistinguishable [67,85]. This is not the case in clinical asthma, however, in which clinical trials have shown corticosteroid therapy to be superior to both cromoglycate [86] and theophyllines [87], In contrast, cromoglycate has significantly greater protective effects than theophylline in this allergic challenge model [88] but the two are indistinguishable clinically [89], Furthermore, the airway protective effect of H]-antihistamines in the late asthmatic reaction to an allergen model is inconsistent with their clinical effect [58,90] and although a diet rich in eicosapentaenoic acid can modify leucocyte leukotriene production and alleviate the late airway response to allergen challenge [91] this dietary manipulation has not been found to have any beneficial effects in clinical asthma [91,92],…”