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Dexpanthenol—Nasenspray vs. Nasensalbe

Prospektive, randomisierte, offene Cross-over-Studie zur mukoziliaren Clearance

Dexpanthenol nasal spray in comparison to dexpanthenol nasal ointment

A prospective, randomised, open, cross-over study to compare nasal mucociliary clearance

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Zusammenfassung

Hintergrund und Fragestellung

Neue Applikationssysteme ermöglichen eine konservierungsmittelfreie Mehrfachgabe von Nasalia (u. a. Dexpanthenol). Ziel der prospektiven, randomisierten, referenzkontrollierten, offenen Cross-over-Studie war der Vergleich von unkonserviertem Dexpanthenol (5%) als Nasenspray und als Nasensalbe bzgl. der mukoziliaren Clearance in vivo.

Methoden

Im Saccharin-Test wurde die mukoziliare Clearance von 20 Probanden verglichen. 20 min vorher wurde entweder Salbe oder Spray appliziert. Die Studie wurde als Prüfung auf Nichtüberlegenheit („non-inferiority“) angelegt.

Ergebnisse

Die Saccharintransportzeit war nach Salbe etwas länger als nach Spray. Mit statistischer Signifikanz (p=0,025) war eine mindestens vergleichbare Verträglichkeit in Bezug auf den mukoziliaren Transport bzw. ein Trend auf Überlegenheit des Nasensprays gegenüber der Nasensalbe anzunehmen.

Fazit

Aufgrund seiner günstigeren Applikationsart bietet sich unkonserviertes Dexpanthenolnasenspray als alternatives Therapeutikum an.

Abstract

Background

Recent technical developments in metered pump systems allow the production and use of preservative-free nasal products. The aim of the current study is to compare the tolerability of a preservative-free dexpanthenol (5%) nasal spray with that of the established dexpanthenol (5%) nasal ointment, also without preservatives. The main outcome measure was in vivo mucociliary clearance.

Method

Mucociliary clearance was assessed by saccharin migration time in 20 volunteers. Wash-out phases were 7 days and the spray or ointment was always applied 20 min before the saccharin test. The study was designed to test for non-inferiority.

Results

Saccharin migration time was slightly longer after ointment administration, however, these were not significantly different to nasal spray. The saccharin migration time showed a significant correlation with the age of the volunteers. The upper confidence limit of dexpanthenol nasal spray was markedly less than that of the ointment. Therefore, dexpanthenol nasal spray is at least equal to if not better than dexpanthenol nasal ointment.

Conclusions

Due to its ease of administration, preservative-free dexpanthenol nasal spray offers a valuable therapeutic alternative.

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Authors and Affiliations

  1. Universitäts-Hals-Nasen-Ohren-Klinik Mannheim, Germany

    T. Verse & F. Riedel

  2. AUDIT Institute for Medical Services and Quality Assurance, Taunusstein, Germany

    N. Klöcker

  3. Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde des Universitätsklinikums Ulm, Germany

    W. Pirsig & M. O. Scheithauer

  4. Universitäts-HNO-Klinik Mannheim, 68135 , Mannheim, Germany

    T. Verse

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  1. T. Verse
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  2. N. Klöcker
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  3. F. Riedel
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  4. W. Pirsig
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  5. M. O. Scheithauer
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Correspondence to T. Verse.

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Verse, T., Klöcker, N., Riedel, F. et al. Dexpanthenol—Nasenspray vs. Nasensalbe. HNO 52, 611–615 (2004). https://doi.org/10.1007/s00106-003-0961-4

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  • DOI: https://doi.org/10.1007/s00106-003-0961-4

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