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

Primary Purpose

Perennial Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Montelukast + Levocetirizine
Levocetirizine
Montelukast
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perennial Allergic Rhinitis focused on measuring PAR

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Soonchunhyang University Bucheon Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Test arm

Comparator arm I

Comparator arm II

Arm Description

Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg

Matching placebo of Montelukast sodium 10mg + Levocetirizine dihydrochloride 5 mg

Montelukast sodium 10mg + matching placebo of Levocetirizine dihydrochloride 5mg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
July 10, 2012
Last Updated
April 4, 2013
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01640535
Brief Title
Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinitis
Keywords
PAR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
283 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test arm
Arm Type
Experimental
Arm Description
Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg
Arm Title
Comparator arm I
Arm Type
Active Comparator
Arm Description
Matching placebo of Montelukast sodium 10mg + Levocetirizine dihydrochloride 5 mg
Arm Title
Comparator arm II
Arm Type
Active Comparator
Arm Description
Montelukast sodium 10mg + matching placebo of Levocetirizine dihydrochloride 5mg
Intervention Type
Drug
Intervention Name(s)
Montelukast + Levocetirizine
Other Intervention Name(s)
Singulair Tablet, Xyzal Tablet
Intervention Description
Tablet, Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime)
Intervention Type
Drug
Intervention Name(s)
Levocetirizine
Other Intervention Name(s)
Xyzal Tablet
Intervention Description
Tablet, Matching placebo of Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime)
Intervention Type
Drug
Intervention Name(s)
Montelukast
Other Intervention Name(s)
Singulair Tablet
Intervention Description
Tablet, Montelukast sodium 10 mg + matching placebo of Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime)
Primary Outcome Measure Information:
Title
Mean Daytime Nasal Symptom Score
Description
Change in Mean Daytime Nasal Symptom Score from baseline at Weeks 3-4(2 weeks) of treatment
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in Mean Nighttime Nasal Symptom from baseline at Weeks 1-2 (2 weeks) and Weeks 3-4 (2 weeks) of treatment
Description
Change in Mean Nighttime Nasal Symptom from baseline at Weeks 1-2 (2 weeks) and Weeks 3-4 (2 weeks) of treatment
Time Frame
4 weeks
Title
Mean Composite Symptom Score
Description
Change in Mean Composite Symptom Score from baseline at Weeks 1-2 (2 weeks) and Weeks 3-4 (2 weeks) of treatment
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyungmi PARK, PhD
Organizational Affiliation
Hanmi Pharmaceutical Company Limited
Official's Role
Study Director
Facility Information:
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon
State/Province
Gyeonggi-do
ZIP/Postal Code
420-767
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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