Active Controlled Trial of the Safety and Tolerability of MP 03-036 (Astepro 0.15%) in Patients With Perennial Allergic Rhinitis

NCT00720382 Phase 3 COMPLETED Results posted

The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.

Details

Lead sponsor	Meda Pharmaceuticals
Phase	Phase 3
Status	COMPLETED
Enrolment	703
Start date	2007-03
Completion	2008-07

Conditions

• Perennial Allergic Rhinitis

Interventions

• 0.15% azelastine hydrochloride
• Mometasone furoate

Primary outcomes

• Change From Baseline on Direct Visual Nasal Exams to 12 Months — Change from baseline to 12 months
  Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation

Countries

United States