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Tuesday 15 January 2008

Azelastine vs. Mometasone: H1 receptor blocker with faster onset of action and higher efficacy

By: Bad Homburg

Azelastine hydrochloride (Allergodil®) nasal spray was found to have a faster onset of action than intranasal corticosteroid mometasone furoate in patients with seasonal allergic rhinitis (SAR), also reducing SAR symptoms more effectively. This is the result of a new study published in July 2007 in the American Journal of Rhinology[1].

Seasonal allergic rhinitis (SAR) is one of the most common allergic conditions in Western industrialised countries. Typical symptoms include watery rhinorrhoea, nasal itching and obstruction as well as frequent sneezing, accompanied by ocular symptoms.  The symptoms of SAR have been shown to have a significant impact on quality of life, i.e. interrupted sleep, general fatigue and concentration problems. Many patients even refrain from outdoor activities during the pollen season. Effective agents with a fast onset of action and only few adverse reactions should thus be the method of choice in the treatment of SAR. Intranasal antihistamines and corticosteroid medications which exert their anti-inflammatory action directly at the inflammation site are available for treatment. The objective of this study was to determine the onset of action of azelastine hydrochloride nasal spray compared with the intranasal corticosteroid mometasone furoate, and to assess the efficacy of these agents with regard to the Total Nasal Symptom Score (TNSS) over a certain period of time.

450 patients with seasonal allergic rhinitis and positive skin prick tests to ragweed (Ambrosia artemisiifolia) took part in this double-blind, randomised and placebo-controlled study. Ragweed is the leading cause of late-summer hay fever in the USA and Canada.  After 30 minutes of controlled exposure to ragweed pollen in an environmental exposure chamber (EEC), the patients were given two puffs of azelastine hydrochloride nasal spray (137 microgram/Hub), an aqueous solution of mometasone furoate monohydrate (50 microgram/Hub) and placebo respectively (each group comprising 15 patients). Thereafter, the TNSS was calculated over a period of 8 hours. Frequent sneezing, rhinorrhoea, nasal itching and nasal obstruction were the most common symptoms observed during the treatment period. Azelastine nasal spray showed a statistically significant improvement in the TNSS at 15 minutes (from baseline) compared with placebo (-12.3 percent) and mometasone (-14.9 percent). At each point in time, azelastine nasal spray also achieved a higher statistically significant efficacy than placebo and corticosteroid mometasone, which is most commonly used to treat SAR.  Mometasone however could not significantly improve the TNSS at any point in time compared to placebo. The maximum reduction in TNSS was significantly greater with azelastine (-45.2%) compared with mometasone (merely -27.1%) and placebo (-23.7%). 

Azelastine (Allergodil® nasal spray) is a topical antihistamine belonging to the family of new histamine H1 receptor blockers.  Azelastine nasal spray is generally well tolerated as a result of its topical application, and provides less exposure to the organism than corticosteroids. Whilst corticosteroids require a regular and consequent use for the treatment of symptoms, azelastine does not need to be applied until symptoms occur. Azelastine has a 12-hour duration of action. A puff per nostril twice daily is adequate to effectively reduce SAR symptoms[2]. The good clinical profile of azelastine with its fast onset of action, long duration of action, high efficacy, good tolerance and flexible application increases compliance and has thus a significant impact on the success rates for seasonal allergic rhinitis (SAR) treatment.

[1] Patel et al., Am J Rhinol; 2007; 21: 499-503

[2] Lumry et al., J Allergy Clin Immunol, 117

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