NCT01018862

A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis

Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 (0.15% Solution) and MP03-33 (0.10% Solution) in Children Ages >6 to <12 With Perennial Allergic Rhinitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 489 (actual)
• Sponsor: Meda Pharmaceuticals · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effectiveness of an Investigational use of an allergy medication (MP03-33) used to treat perennial allergic rhinitis (PAR) to placebo (a nasal spray that contains no medicine). In addition, the study will also compare the safety and effectiveness of an investigational use of another allergy medication (MP03-36) used to treat perennial allergic rhinitis to placebo.

Detailed description

in Children Ages \>6 to \<12 with Perennial Allergic Rhinitis (PAR)

Conditions

• Perennial Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Azelastine hydrochloride nasal spray 0.15%	822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
DRUG	Azelastine hydrochloride nasal spray 0.10%	548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
DRUG	Placebo	0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2009-11-25
• Last updated: 2012-06-11
• Results posted: 2012-06-11

Locations

39 sites across 1 country: United States