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Clinical Drug Investigation

, Volume 27, Issue 7, pp 453–461 | Cite as

A Comparison of Ebastine 10mg Fast-Dissolving Tablet with Oral Desloratadine and Placebo in Inhibiting the Cutaneous Reaction to Histamine in Healthy Adults

  • Rosa M. Antonijoan
  • Consuelo García-Gea
  • Montserrat Puntes
  • Marta Valle
  • Ramon Esbri
  • Josep ForteaEmail author
  • Manuel J. Barbanoj
Original Research Article

Abstract

Background and objective: Ebastine is a long-acting, second-generation selective histamine H1 receptor antagonist. The pharmacodynamics of a new 10mg fast-dissolving tablet (FDT) oral lyophilisate tablet formulation of ebastine were compared with those of desloratadine and placebo following histamine skin intradermal test challenge. The acceptability of the FDT was also assessed.

Methods: This was a double-blind, double-dummy, placebo-controlled, randomised, crossover, three-period study in 36 healthy adults. The histamine skin intradermal test (0.05mL of 100 μg/mL solution) was administered into volunteers’ forearms, and wheal area was measured 15 minutes later. Ebastine 10mg FDT, desloratadine 5mg capsule or placebo were given on days 1–5. On day 1, a skin intradermal test was performed at baseline, then every 20 minutes for 2 hours after administration and at 24 hours. The final skin intradermal test was on day 6, 24 hours after the last drug dose. Subjective symptoms (itching, heat and pain) were assessed on day 1 for 2 hours following the first drug dose. There was a washout period of 7–10 days between treatments. At study end, the acceptability of the new ebastine formulation was evaluated using a questionnaire.

Results: Ebastine 10mg inhibited the wheal response to histamine significantly more than desloratadine 5mg or placebo 24 hours after 5 days’ treatment (mean difference between treatments in wheal area reduction from baseline: 26.7%, p < 0.0001; 46.9%, p < 0.0001, respectively), and after 24 hours on day 1 (mean difference: 16.2%, p = 0.0082; 34.2%, p < 0.0001, respectively). The results with desloratadine were also significantly different from placebo on day 1 and after 5 days, but less than with ebastine after 5 days (difference, desloratadine vs placebo: 20.2%, p = 0.0001). No differences in itching, heat and pain were observed between the treatments. Most participants (70%) preferred the FDT, and all reported that it made adherence easier.

Conclusion: Ebastine 10mg FDT demonstrated significantly superior antihistamine activity compared with desloratadine and placebo.

Keywords

Histamine Allergic Rhinitis Loratadine Chronic Urticaria Seasonal Allergic Rhinitis 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgements

This study received funding from Almirall SA. Mr Esbri and Dr Fortea are employees of Almirall SA, the company that manufactures ebastine. The other authors have no conflicts of interest that are directly relevant to the content of this study.

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Copyright information

© Adis Data Information BV 2007

Authors and Affiliations

  • Rosa M. Antonijoan
    • 1
  • Consuelo García-Gea
    • 1
  • Montserrat Puntes
    • 1
  • Marta Valle
    • 1
  • Ramon Esbri
    • 2
  • Josep Fortea
    • 2
    Email author
  • Manuel J. Barbanoj
    • 1
  1. 1.Department of Clinical PharmacologyHospital de la Santa Creu i Sant PauBarcelonaSpain
  2. 2.Global Marketing & Medical AffairsAlmirall SABarcelonaSpain

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