"The trial was designed to show that the nasal spray was at least equivalent to use of the oral drug," said Ellen Sher, MD, Clinical Assistant Professor of Medicine, University of Medicine and Dentistry of New Jersey, Newark, New Jersey, United States. "However, we found that while both drug were effective in controlling symptoms, azelastine was consistently superior in all four symptoms domains -- itchy nose, nasal congestion, runny nose and sneezing."

Dr. Sher and colleagues pooled the results of two trials -- the Azelastine vs. Cetirizine Trial I and II (ACT I, Act II) -- in which a 1-week placebo run-in period determined baseline total nasal symptom score figures. Patients were then randomized to receive azelastine nasal spray plus placebo capsules or a placebo saline spray plus cetirizine tablets.

"While the saline nasal spray is supposed to be a placebo, we know that such sprays have some benefit to patients, so if anything there was an advantage for cetirizine," Dr. Sher said in her poster presentation on March 7^th.

But as it turned out, in the overall results, the 331 patients on azelastine had an average 5.08-point improvement in total nasal symptom scores compared to the 330 patients on cetirizine, who recorded an average of 4.11-point improvement. That difference reached statistical significance at the P =.005 level, Dr. Sher said.

The pooled results show that azelastine nasal spray outperformed oral cetirizine in the four symptom domains:

- 23.7% improvement in itchy nose symptoms vs. 19.7% for cetirizine, a numerical superiority.
- 19.2% improvement in nasal congestion symptoms compared to 14.9% with cetirizine (P =.02).
- 26.5% improvement in runny nose symptoms compared to 20.07% with cetirizine (P <.01).
- 33.7% improvement in sneezing symptoms compared to 25.6% with cetirizine (P <.01).

The studies were supported by MedPointe Pharmaceuticals, Somerset, New Jersey, United States.


[Presentation title: Azelastine Nasal Spray Compared to Cetirizine in the Treatment of Patients With Seasonal Allergic Rhinitis: A Pooled Analysis of Two Double-Blind, Multicenter Studies. Abstract 1231]

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