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COMPLETEDPHASE3

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

NCT01640535•Hanmi Pharmaceutical Company Limited

View on ClinicalTrials.gov

Summary

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

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

Eligibility

Age

15 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, South Korea

Key Dates

Start Date

June 1, 2012

Primary Completion Date

February 1, 2013

Completion Date

February 1, 2013

Last Updated

April 8, 2013

Enrollment

283

ACTUAL participants

Conditions

Perennial Allergic Rhinitis

Interventions

Montelukast + Levocetirizine

DRUG

Levocetirizine

DRUG

Montelukast

DRUG

A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis

NCT01425632

Perennial Allergic Rhinitis

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TERMINATEDPHASE3

Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis

NCT04874714

Allergic RhinoconjunctivitisPerennial Allergic Rhinitis+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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