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

Phase 3

Completed

• Conditions: Perennial Allergic Rhinitis
• Interventions: Drug: Montelukast + Levocetirizine; Drug: Montelukast; Drug: Levocetirizine

• Registration Number: NCT01640535
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief 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

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-10
• Study First Submitted QC: 2012-07-11
• Study First Posted: 2012-07-13
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-04
• Last Update Posted: 2013-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 283

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test arm	Montelukast + Levocetirizine	Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg
Comparator arm II	Montelukast	Montelukast sodium 10mg + matching placebo of Levocetirizine dihydrochloride 5mg
Comparator arm I	Levocetirizine	Matching placebo of Montelukast sodium 10mg + Levocetirizine dihydrochloride 5 mg

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Soonchunhyang University Bucheon Hospital; 🇰🇷 Bucheon, Gyeonggi-do, Korea, Republic of