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

Study Overview
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Brief Summary
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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.

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

Official Title
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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

Conditions
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Perennial Allergic Rhinitis

Intervention / Treatment
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* Drug: Montelukast + Levocetirizine
* Drug: Levocetirizine
* Drug: Montelukast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAR