Nasal Antihistamines

Two head-to-head clinical trials indicate that azelastine is an effective choice compared with oral antihistamines.

Azelastine outperformed Zyrtec©1,2*†

In 2 head-to-head double blind studies (N=661), ASTELIN brand of azelastine HCI::

  • Improved TNSS
    • Patients treated with ASTELIN had a 27% greater improvement from baseline in Total Nasal Symptom Score (TNSS, made up of nasal congestion, runny nose, itchy nose, and sneezing) over cetirizine in ACT I, which was statistically significant1
    • In ACT II, ASTELIN demonstrated a 22% greater improvement from baseline in TNSS over cetirizine, which did not attain statistical significance2
  • Significantly improved quality of life
    • Patients receiving ASTELIN reported significantly greater improvements in overall RQLQ scores compared with patients receiving cetirizine plus placebo saline nasal spray in both trials (P≤.05).1,2
    • ASTELIN was associated with a 27% improvement in quality of life measures in ACT I and a 36% improvement in ACT II compared with patients receiving cetirizine plus placebo saline nasal spray.1,2

Azelastine was effective when Allegra© fell short3†

In patients who did not get adequate relief (N=334), ASTELIN brand of azelastine HCI:

  • 2-week double blind study in seasonal allergic rhinitis patients who remained moderately symptomatic after 1 week of treatment with Allegra
  • Primary end point: change from Claritin baseline to day 14 in TNSS* vs placebo

Azelastine was effective when Claritin© fell short4†

In patients who did not get adequate relief (N=428), ASTELIN brand of azelastine HCI:

  • 2-week double blind study in seasonal allergic rhinitis patients who remained moderately symptomatic after 1 week of treatment with Claritin
  • Primary end point: change from Claritin baseline to day 14 in TNSS* vs placebo

*In head-to-head, multicenter, double-blind trials: Azelastine Cetirizine trials (ACT) I and II with 661 SAR patients.
†Study conducted with ASTELIN brand azelastine HCI nasal spray.

Zyrtec (cetirizine HCI) is a registered trademark of McNeil-PPC, Inc.
Allegra (fexofenadine HCI) is a registered trademark of the sanofi-aventis Group.
Claritin (loratadine) is a registered trademark of Schering-Plough Corporation.

About Oral Antihistamines

Oral antihistamines are one of the most common medications used to relieve nasal allergy symptoms. Unfortunately, oral antihistamines taken by themselves, while readily available over the counter, have limited objective effect in relieving nasal congestion.5

1Corren J, Storms W, Bernstein J, Berger W, Nayak A, Sacks H; Azelastine Cetirizine Trial No. 1 (ACT I) Study Group. Effectiveness of azelastine nasal spray compared with oral cetirizine in patients with seasonal allergic rhinitis. Clin Ther. 2005;27(5):543-553.
2Berger W, Hampel F, Bernstein J, Shah S, Sacks H, Meltzer EO. Impact of azelastine nasal spray on symptoms and quality of life compared with cetirizine oral tablets in patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2006;97(3):375-381.
3LaForce CF, Corren J, Wheeler WJ, Berger WE; Rhinitis Study Group. Efficacy of azelastine nasal spray in seasonal allergic rhinitis patients who remain symptomatic after treatment with fexofenadine. Ann Allergy Asthma Immunol. 2004;93(2):154-159. 4Berger WE, White MV; Rhinitis Study Group. Efficacy of azelastine nasal spray in patients with an unsatisfactory response to loratadine. Ann Allergy Asthma Immunol. 2003;91(2):205-211.
5Dykewicz MS et al. Ann Allergy Asthma Immunol. 1998;81:478-518.