Multicenter, double-blind, multiple-dose, parallel-groups efficacy and safety trial of azelastine, chlorpheniramine, and placebo in the treatment of spring allergic rhinitis

Weiler, John M.; Donnelly, Arlene; Campbell, Bruce H.; Connell, John T.; Diamond, Louis K.; Hamilton, Lyle H.; Rosenthal, Richard R.; Hemsworth, George R.; Perhach, James L.

doi:10.1016/0091-6749(88)90082-6

Cited by 38 publications

(22 citation statements)

References 18 publications

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“…In the present study, we have confirmed previous results obtained by other investigators concerning the favourable effect of azelastine on both rhinitis symptoms and antihistamine medication requirements [9,10]. However, we have not been able to demonstrate any significant anti-asthmatic effect of the drug.…”

Section: Discussionsupporting

confidence: 92%

“…a phthala/inone derivative, is a new potent, long acting, orally active anti-allergic compound with particularly strong Hphistamine receptor antagonistie properties [8]. which has been demonstrated to be efieclive and safe in both seasonal [9] and perennial [10] allergic rhinitis. Moreover., in animal models azelastine inhibits the immunologie and non-immunologie histamine release [11].…”

mentioning

confidence: 99%

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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

Balzano

Masi

et al. 1992

Clin Experimental Allergy

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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)

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Section: Discussionsupporting

confidence: 92%

mentioning

confidence: 99%

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

Balzano

Masi

et al. 1992

Clin Experimental Allergy

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“…In vivo human clinical trials have shown oral azelastine to relax human airway smooth muscle [13], inhibit skin test reactivity to hislamine, codeine and antigen and to reduce antigen-induced histamine release in a skin chamber [14]. Furthermore, in clinical trials designed to study seasonal grass and ragweed allergic rhinitis, azelastine, in doses ranging from 0-5 to 2 mg b.i.d., proved more effective than placebo and chlorpheniramine in relieving symptoms [15]. Because of this wide range of actions of azelastine, we initiated a clinical trial to investigate its effects on the immediate nasal allergic reaction in vivo.…”

Section: Introductionmentioning

confidence: 99%

The effect of azelastine on the early allergic response

Shin

Baroody

Kagey‐Sobotka

et al. 1992

Clin Experimental Allergy

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To study the effect of azelastine on the immediate reaction to nasal allergen challenge, we performed a double blind, placebo-controlled cross-over clinical trial. Thirteen subjects with seasonal allergic rhinitis underwent nasal challenge with antigen 4 hr after a single oral 2 mg dose of azelastine. The response was monitored by counting the number of sneezes and by measuring the levels of histamine, prostaglandin D2, immunoreactive sulphidopeptide leukotrienes, kinis and TAME-esterase activity in recovered nasal lavages. After a single dose of azelastine, there was a significant reduction in sneezing (10 vs 2, P = 0.01) and in the median levels of recovered TAME-esterase activity (63.1 vs 17.5 c.p.m. x 10(-3), P = 0.01), immunoreactive sulphidopeptide leukotrienes (7.5 vs 2.1 ng/ml, P = 0.03) and kinins (1370 vs 251 pg/ml, P = 0.03), with no significant reduction in the median levels of histamine (3.7 vs 1.2 ng/ml, P = 0.2) and prostaglandin D2 (70 vs 70 pg/ml, P = 0.2) compared to placebo (numbers represent total increase over diluent challenge). These results suggest that azelastine does not inhibit mast cell activation but affects the consequences of released histamine, namely sneezing, increased vascular permeability and the generation of kinins. The results further suggest that other cells, in addition to mast cells, might be responsible for the generation of leukotrienes during the early allergic response, and that azelastine reduces their ability to generate this mediator or that inhibition of leukotriene release from mast cells occurs at lower drug concentrations.

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“…Those published report that clemastine (1mg three times daily) and brompheniramine (12mg twice daily) helped control symptoms of hayfever2–4 while chlorphenamine (4mg four times daily) did not 5…”

Section: Clinical Effectivenessmentioning

confidence: 99%

Oral antihistamines for allergic disorders

2002

DTB

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Multicenter, double-blind, multiple-dose, parallel-groups efficacy and safety trial of azelastine, chlorpheniramine, and placebo in the treatment of spring allergic rhinitis

Cited by 38 publications

References 18 publications

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

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

The effect of azelastine on the early allergic response

Oral antihistamines for allergic disorders

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