Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Perennial Allergic Rhinitis
• Intervention / Treatment: Drug: Montelukast + Levocetirizine; Drug: Levocetirizine; Drug: Montelukast

Detailed Description

randomized, double-blind, active-controlled, multicenter, phase 3 trial

• Study Type: Interventional
• Enrollment (Actual): 283
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
      • SoonChunHyang University Bucheon Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with at least 2 years history of PAR prior to the study
• Positive results of skin prick test
• Patients who provided a signed written informed consent form
• Patients who are able and willing to complete subject diaries
• Patients who agree to maintain consistency in their surroundings throughout the study period
• At Visit, 2 patients whose symptom scores recorded in the subject diary meet all of the followings during the last one week of baseline period A.Daily mean of 6 points or above for Daytime Nasal Symptom Score (maximum 12 points) B.Daily mean of 1.8 points or above for Daytime Nasal Obstruction Symptom Score (maximum 3 points)

Exclusion Criteria:

• Patients also with non-allergic rhinitis with different causes.
• Patients with severe asthma who meet the followings.
• Presence of nasal polyps or any clinically important nasal anomaly.
• History of acute • chronic sinusitis within 30 days of Visit 1
• History of intranasal / eye surgeries within 3 months of Visit 1
• Initiation of immunotherapy or dose modification within 1 month prior to Visit 1
• Upper respiratory infections including cold and systemic infections within 3 weeks of Visit 1.
• Chronic use of tricyclic antidepressants, beta agonists, bronchodilators, etc. that may affect the efficacy of study drug
• At Visit 2, patients who recorded Daytime Nasal Symptom Scores for fewer than 4 days in the subject diary during the last one week of baseline period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test arm; Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg	Drug: Montelukast + Levocetirizine; Tablet, Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime); Other Names: Singulair Tablet, Xyzal Tablet
Active Comparator: Comparator arm I; Matching placebo of Montelukast sodium 10mg + Levocetirizine dihydrochloride 5 mg	Drug: Levocetirizine; Tablet, Matching placebo of Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime); Other Names: Xyzal Tablet
Active Comparator: Comparator arm II; Montelukast sodium 10mg + matching placebo of Levocetirizine dihydrochloride 5mg	Drug: Montelukast; Tablet, Montelukast sodium 10 mg + matching placebo of Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime); Other Names: Singulair Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Daytime Nasal Symptom Score	Change in Mean Daytime Nasal Symptom Score from baseline at Weeks 3-4(2 weeks) of treatment	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Nighttime Nasal Symptom from baseline at Weeks 1-2 (2 weeks) and Weeks 3-4 (2 weeks) of treatment	Change in Mean Nighttime Nasal Symptom from baseline at Weeks 1-2 (2 weeks) and Weeks 3-4 (2 weeks) of treatment	4 weeks
Mean Composite Symptom Score	Change in Mean Composite Symptom Score from baseline at Weeks 1-2 (2 weeks) and Weeks 3-4 (2 weeks) of treatment	4 weeks

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Study Director: Kyungmi PARK, PhD, Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: July 10, 2012
• First Submitted That Met QC Criteria: July 11, 2012
• First Posted (Estimate): July 13, 2012

Study Record Updates

• Last Update Posted (Estimate): April 8, 2013
• Last Update Submitted That Met QC Criteria: April 4, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: PAR
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Montelukast; Cetirizine; Levocetirizine
• Other Study ID Numbers: HM-MOLZ-301