NCT01368445

A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Seasonal Allergies

Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 in Patients With Seasonal Allergic Rhinitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 617 (actual)
• Sponsor: Meda Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15% azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice daily in patients with seasonal allergic rhinitis.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	azelastine hydrochloride 0.15% Nasal Spray	1644 mcg, 2 sprays per nostril twice daily AM \& PM)
DRUG	azelastine hydrochloride 0.15% and Placebo	822 mcg azelastine hydrochloride 0.15%, 2 sprays per nostril once daily (AM) and 0mg placebo spray 2 sprays per nostril once daily (PM)
DRUG	Azelastine 0.1%, Nasal Spray	1096 mcg, Azelastine 0.1%,2 sprays per nostril twice daily (AM \& PM)

Timeline

• Start date: 2006-08-01
• Primary completion: 2006-11-01
• Completion: 2008-04-01
• First posted: 2011-06-08
• Last updated: 2011-10-06

Locations

30 sites across 1 country: United States