Advertisement

Clinical Drug Investigation

, Volume 21, Issue 1, pp 25–32 | Cite as

Efficacy and Tolerability of Once-Daily 5mg Desloratadine, an H1-Receptor Antagonist, in Patients with Seasonal Allergic Rhinitis

Assessment during the Spring and Fall Allergy Seasons
  • Eli O. Meltzer
  • Bruce M. Prenner
  • Anjuli Nayak
Clinical Use

Abstract

Objective

To evaluate the efficacy and tolerability of desloratadine 5mg once daily, a new, selective, H1-receptor antagonist, for the treatment of patients with seasonal allergic rhinitis (SAR) during the two major pollen seasons in the USA.

Design

Two multicentre, randomised, double-blind, placebo-controlled, parallel-group investigations in patients with SAR are reported, one conducted during the spring (172 and 174 patients in the desloratadine and placebo groups, respectively) and the other during the fall (164 patients each in the desloratadine and placebo groups) allergy season.

Study Participants

Patients 12 years of age or older with clinically symptomatic SAR and a minimum 2-year history of SAR.

Interventions

Desloratadine 5mg or placebo once daily for 14 days following a 1-week screening period.

Main Outcome Measures

The primary efficacy assessment was the mean change from baseline in the average reflective am/pm total symptom score (TSS) averaged over the 2-week study period.

Results

In both seasons, desloratadine 5mg once daily resulted in a significant improvement in TSS for patients with SAR (p < 0.01 and p = 0.02, respectively) over the 2-week study. Adverse events reported were mild to moderate in severity and similar to placebo. Assessment of sedation and ECG data revealed no clinically significant changes from baseline with desloratadine- or placebo-treated patients.

Conclusion

Desloratadine 5mg once daily was effective and well tolerated in the treatment of symptoms associated with SAR following the first dose of therapy and continuing for the 2-week duration of the study during both the spring and fall allergy seasons.

Keywords

Loratadine Seasonal Allergic Rhinitis Desloratadine Total Symptom Score Allergy Season 
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

Funding was provided by Schering-Plough Research Institute, Kenilworth, New Jersey, USA.

References

  1. 1.
    American Academy of Allergy Asthma & Immunology. The Allergy Report, Volume 1: Overview of Allergic Diseases. 2000. Milwaukee, WI, American Academy of Allergy, Asthma & ImmunologyGoogle Scholar
  2. 2.
    Schoenwetter WF. Allergic rhinitis: Epidemiology and natural history. Allergy Asthma Proc 2000; 21: 1–6PubMedCrossRefGoogle Scholar
  3. 3.
    Nightingale CH. Treating allergic rhinitis with second-generation antihistamines. Pharmacotherapy 1996; 16: 905–14PubMedGoogle Scholar
  4. 4.
    Corry DB, Kheradmand F. Induction and regulation of the IgE response. Nature 1999; 402: B18–B23PubMedCrossRefGoogle Scholar
  5. 5.
    Kreutner W, Hey JA, Anthes J, et al. Preclinical pharmacology of desloratadine, a selective and nonsedating histamine H1 receptor antagonist: 1st communication: Receptor selectivity, antihistaminic activity, and antiallergenic effects. Arzneimittelforschung 2000; 50: 345–52PubMedGoogle Scholar
  6. 6.
    Affrime M, Gupta S, Banfield C, et al. A pharmacokinetic profile of desloratadine in healthy adults including elderly subjects. Clin Pharmacokinet. In pressGoogle Scholar
  7. 7.
    Gupta S, Padhi D, Banfield C, et al. The oral bioavailability of desloratadine is unaffected by food, [abstract] Allergy 2000; 55 Suppl. 63: 268Google Scholar
  8. 8.
    Banfield C, Hunt T, Reyderman L, et al. Lack of interaction between desloratadine and erythromycin. Clin Pharmacokinet. In pressGoogle Scholar
  9. 9.
    Banfield C, Herron J, Keung A, et al. Desloratadine has no electrocardiographic or pharmacodynamic interactions with ketoconazole. Clin Pharmacokinet. In pressGoogle Scholar
  10. 10.
    Marino M, Glue P, Herron JM, et al. Lack of electrocardiographic effects of multiple high doses of desloratadine. [abstract] Allergy 2000; 55 Suppl. 63: 279Google Scholar
  11. 11.
    Hadley JA. Evaluation and management of allergic rhinitis. Med Clin North Am 1999; 83: 13–25PubMedCrossRefGoogle Scholar
  12. 12.
    Day JH, Briscoe M, Widlitz MD. Cetirizine, loratadine, or placebo in subjects with seasonal allergic rhinitis: Effects after controlled ragweed pollen challenge in an environmental exposure unit. J Allergy Clin Immunol 1998; 101: 638–45PubMedCrossRefGoogle Scholar
  13. 13.
    Gutkowski A, Bedard PM, Del Carpio J, et al. Comparison of the efficacy and safety of loratadine, terfenadine, and placebo in the treatment of seasonal allergic rhinitis. J Allergy Clin Immunol 1988; 81: 902–7PubMedCrossRefGoogle Scholar
  14. 14.
    Lockey RF, Widlitz MD, Mitchell DQ, et al. Comparative study of cetirizine and terfenadine versus placebo in the symptomatic management of seasonal allergic rhinitis. Ann Allergy Asthma Immunol 1996; 76: 448–54PubMedCrossRefGoogle Scholar
  15. 15.
    Bronsky E, Falliers CJ, Kaiser HB, et al. Effectiveness and safety of fexofenadine, a new nonsedating H1 -receptor antagonist, in the treatment of fall allergies. Allergy Asthma Proc 1998; 19: 135–41PubMedCrossRefGoogle Scholar
  16. 16.
    Casale TB, Andrade C, Qu R. Safety and efficacy of once-daily fexofenadine HCl in the treatment of autumn seasonal allergic rhinitis. Allergy Asthma Proc 1999; 20: 193–8PubMedCrossRefGoogle Scholar

Copyright information

© Adis International Limited 2001

Authors and Affiliations

  • Eli O. Meltzer
    • 1
  • Bruce M. Prenner
    • 2
  • Anjuli Nayak
    • 3
  1. 1.Allergy and Asthma Medical Group and Research CenterSan DiegoUSA
  2. 2.Allergy Associates Medical GroupSan DiegoUSA
  3. 3.Peoria School of MedicineUniversity of IllinoisPeoriaUSA

Personalised recommendations