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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Perennial Allergic Rhinitis
Intervention	Drug: Montelukast + Levocetirizine Drug: Levocetirizine Drug: Montelukast
Phase	Phase 3
Sponsor	Hanmi Pharmaceutical Company Limited
Responsible Party	Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier	NCT01640535
First Received	July 10, 2012
Last Updated	April 4, 2013
Last verified	April 2013

Tracking Information[ + expand ][ + ]

First Received Date	July 10, 2012
Last Updated Date	April 4, 2013
Start Date	June 2012
Estimated Primary Completion Date	February 2013
Current Primary Outcome Measures	Mean Daytime Nasal Symptom Score [Time Frame: 4 weeks] [Designated as safety issue: No]Change in Mean Daytime Nasal Symptom Score from baseline at Weeks 3-4(2 weeks) of treatment
Current 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 [Time Frame: 4 weeks] [Designated as safety issue: No]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 [Time Frame: 4 weeks] [Designated as safety issue: No]Change in Mean Composite Symptom Score from baseline at Weeks 1-2 (2 weeks) and Weeks 3-4 (2 weeks) of treatment

Descriptive Information[ + expand ][ + ]

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
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 Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Perennial Allergic Rhinitis
Intervention	Drug: Montelukast + Levocetirizine Tablet, Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime) Other Names: Singulair Tablet, Xyzal TabletDrug: Levocetirizine Tablet, Matching placebo of Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime) Other Names: Xyzal TabletDrug: Montelukast Tablet, Montelukast sodium 10 mg + matching placebo of Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime) Other Names: Singulair Tablet
Study Arm (s)	Experimental: Test arm Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg Active Comparator: Comparator arm I Matching placebo of Montelukast sodium 10mg + Levocetirizine dihydrochloride 5 mg Active Comparator: Comparator arm II Montelukast sodium 10mg + matching placebo of Levocetirizine dihydrochloride 5mg

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	283
Estimated Completion Date	February 2013
Estimated Primary Completion Date	February 2013
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
Gender	Both
Ages	15 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Korea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT01640535
Other Study ID Numbers	HM-MOLZ-301
Has Data Monitoring Committee	No
Information Provided By	Hanmi Pharmaceutical Company Limited
Study Sponsor	Hanmi Pharmaceutical Company Limited
Collaborators	Not Provided
Investigators	Study Director: Kyungmi PARK, PhD Hanmi Pharmaceutical Company Limited
Verification Date	April 2013

Locations[ + expand ][ + ]