Topische Antihistaminika bei saisonaler allergischer Rhinitis : eine Untersuchung mit Dimetindenmaleat als Nasenspray
Topical antihistamines in seasonal allergic rhinitis - A trial with dimethindenemaleate (DMM) as a nasal spray. This study investigates the efficacy and safety of dimethindenemaleate (0,1%) vs. placebo nasal spray in the therapy of seasonal allergic Rhinitis. 175 patients were randomised in a multicenter placebo-controlled double blind study (phase III) with parallel groups. This thesis investigates especially DMM nasal spray in comparison with other frequently used topical antihistamines: azelastine and levocabastine. The efficacy is measured from the patients rating at baseline (nasal) and the mean of the third evening and the forth morning. This "effect" was the same in both groups. Evaluating efficacy patients rated "symptom free / good improvement" in 44% (DMM) and 36% (Placebo) of the cases. The study doctors rated the efficacy in 46% (DMM) and 50% (Placebo) of the cases as "symptom free / good improvement". Tolerability was rated "very good /good" in 90% (Placebo) and 89% (DMM) of the cases by the patients. The doctors decided for "very good /good" in 95% of the cases (both groups). The improvement of symptoms in the first week was 41% (DMM) and. 39% (Placebo), after 2 weeks it was 56% (DMM) and. 59% (Placebo). Patients vigilance improved for 18% - therefore there was no sedative adverse effect of DMM. Efficacy measurements in the first week showed inferiority of DMM compared to azelastine and levocabastine. The onset of action of DMM is faster then the other nasal antihistamines analysed. Adverse reactions were more frequent in patients applying levocabastine, then DMM. In this aspect and in vigilance DMM is equal to azelastine. Tolerability is very good in all three groups with minimum of 89%. Even though it is inferior in efficacy compared to the other antihistamines, one cannot deny its potency and very good tolerability. Remarkable is the efficacy of the by definition non-active placebo. The superiority of the active substance is notable in only few parameters, with the main criterion missing. This fact is mainly due to "bad" weather and an "active" placebo.
info:eu-repo/classification/ddc/610, Medizin, DMM, Dimetindenmaleat, seasonal allergic rhinits, azelastine, levocabastine, topical nasal spray
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