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

Last updated: April 4, 2013
Sponsor: Hanmi Pharmaceutical Company Limited
Overall Status: Completed

Phase

3

Condition

Nasal Obstruction

Common Cold

Rhinitis, Allergic, Perennial

Treatment

N/A

Clinical Study ID

NCT01640535
HM-MOLZ-301
  • Ages > 15
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 studyperiod

  • At Visit, 2 patients whose symptom scores recorded in the subject diary meet all ofthe followings during the last one week of baseline period A.Daily mean of 6 points orabove for Daytime Nasal Symptom Score (maximum 12 points) B.Daily mean of 1.8 pointsor above for Daytime Nasal Obstruction Symptom Score (maximum 3 points)

Exclusion

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 ofVisit 1.

  • Chronic use of tricyclic antidepressants, beta agonists, bronchodilators, etc. thatmay affect the efficacy of study drug

  • At Visit 2, patients who recorded Daytime Nasal Symptom Scores for fewer than 4 daysin the subject diary during the last one week of baseline period

Study Design

Total Participants: 283
Study Start date:
June 01, 2012
Estimated Completion Date:
February 28, 2013

Study Description

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

Connect with a study center

  • Soonchunhyang University Bucheon Hospital

    Bucheon, Gyeonggi-do 420-767
    Korea, Republic of

    Site Not Available

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