A dose-ranging study of the efficacy and safety of azelastine nasal spray in the treatment of seasonal allergic rhinitis with an acute model.

BACKGROUND

Oral azelastine, a nonsteroidal antiinflammatory respiratory investigational drug has demonstrated activity in the treatment of allergic rhinitis and asthma with a good safety profile.

METHODS

Azelastine nasal spray was compared with sustained-release oral chlorpheniramine maleate and placebo for efficacy and safety in the treatment of seasonal allergic rhinitis in a double-dummy, two-center, 2-day, double-blind, randomized, dose-ranging, parallel-groups, onset and duration of action study. Two hundred sixty-four subjects reported to an outdoor park on Saturday morning during the height of the fall pollen season and remained there for 8 hours that day and the next to ensure maximal exposure to seasonal aeroallergens. Symptom diary cards were collected hourly Saturday from 8:00 AM to 10:00 AM (baseline period). Subjects who had sufficient symptoms were randomized into five groups and received medication at 10:00 AM and 10:00 PM on Saturday and at 10:00 AM on Sunday: azelastine 0.1% (1 spray [0.12 mg] per nostril every 12 hours, 2 sprays per nostril every every 12 hours, or 2 sprays per nostril once daily), Chlor-Trimeton Repetabs (12 mg twice daily), or placebo (twice daily). Diary cards were completed hourly (11:00 AM to 4:00 PM) and at 6:00, 8:00, and 10:00 PM on Saturday and again hourly on Sunday (from 8:00 AM to 4:00 PM) to evaluate rhinitis symptoms and adverse events.

RESULTS

Two hundred fifty-nine subjects completed the study. The groups that received 2 sprays of azelastine per nostril once and twice daily and the chlorpheniramine group had statistically significantly more improvement in total rhinitis symptoms than the placebo group without serious adverse events.

CONCLUSIONS

This study supports a once to twice daily dosing regimen for 2 sprays of 0.1% azelastine in the acute treatment of allergic rhinitis with onset of action within 2 to 3 hours.