Effectiveness of desloratadine 5 mg once daily in patients with symptoms of seasonal allergic rhinitis: results of a Canadian multicenter, open-label trial

Clin Ther. 2007 Mar;29(3):419-26. doi: 10.1016/s0149-2918(07)80080-4.

Abstract

Background: Seasonal allergic rhinitis (SAR) is an inflammatory response to seasonal allergens. Desloratadine, a once-daily selective histamine H(1)-receptor antagonist, has been reported to be efficacious in relieving symptoms of SAR in controlled clinical trials. However, to assess the actual effectiveness of a drug, it is important to examine information about its use in routine clinical practice.

Objective: The Partners in Allergy Control and Therapy (PACT) study examined the effectiveness of desloratadine in patients with SAR symptoms receiving treatment in a community setting of primary care physicians in Canada.

Methods: Patients with symptoms of SAR received desloratadine 5 mg once daily for 7 days during the spring-summer allergy season (April-July 2002). Patients rated their SAR symptoms along with their physicians by completing a questionnaire at baseline and day 7. Nasal, ocular, respiratory, and overall symptoms were rated on a scale of 0 (no symptoms evident) to 3 (severe/interfere with activities of daily living and/or sleeping). Physicians were asked to keep a record of adverse events reported by patients. The Wilcoxon signed-rank test was used to evaluate symptom severity scores. A 2-way (time x treatment), repeated measures, mixed analysis of variance (ANOVA) model was constructed to assess differences in variables over time.

Results: A total of 6829 patients participated in the study. Patients reported nasal stuffiness/congestion as their most severe symptom. Just over half (50.1%) of patients were receiving another medication for SAR at study entry; 29.7% were receiving an intranasal corticosteroid. After 7 days of treatment with desloratadine, individual symptom scores and overall symptom scores were significantly reduced compared with baseline (all scores, P<0.001). An improvement in nasal/stuffiness/ congestion was reported by 88.0% of patients. The ANOVA detected a statistically significant incremental benefit with desloratadine and an intranasal corticosteroid compared with desloratadine monotherapy (P<0.001). No severe adverse events were reported.

Conclusion: Desloratadine 5 mg once daily was associated with significant improvement in symptoms of SAR, and appeared to provide additional benefit in relieving moderate to severe nasal stuffiness/congestion in 6786 patients receiving 7-day treatment in an actual practice setting of primary care physicians in Canada.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Analysis of Variance
  • Anti-Allergic Agents / administration & dosage*
  • Canada
  • Child
  • Drug Administration Schedule
  • Female
  • Histamine H1 Antagonists, Non-Sedating / administration & dosage*
  • Humans
  • Loratadine / administration & dosage
  • Loratadine / analogs & derivatives*
  • Male
  • Middle Aged
  • Primary Health Care
  • Rhinitis, Allergic, Seasonal / drug therapy*
  • Statistics, Nonparametric
  • Surveys and Questionnaires
  • Treatment Outcome

Substances

  • Anti-Allergic Agents
  • Histamine H1 Antagonists, Non-Sedating
  • Loratadine
  • desloratadine