Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial

NCT01640535 Phase 3 COMPLETED

The purpose of this study is to demonstrate that the efficacy of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride is superior to that of Levocetirizine and Montelukast monotherapies and to compare the safety and tolerability of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride to those of Levocetirizine and Montelukast monotherapies in Perennial Allergic Rhinitis (PAR) patients.

Details

Lead sponsor	Hanmi Pharmaceutical Company Limited
Phase	Phase 3
Status	COMPLETED
Enrolment	283
Start date	2012-06
Completion	2013-02

Conditions

• Perennial Allergic Rhinitis

Interventions

• Montelukast + Levocetirizine
• Levocetirizine
• Montelukast

Primary outcomes

• Mean Daytime Nasal Symptom Score — 4 weeks
  Change in Mean Daytime Nasal Symptom Score from baseline at Weeks 3-4(2 weeks) of treatment

Countries

South Korea