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

NCT01640535 | Completed Phase 3

• 1 other identifier: HM-MOLZ-301
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 1

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.

Conditions

Perennial Allergic Rhinitis

Keywords

PAR

Outcome Measures

Primary Outcomes (1)

• Mean Daytime Nasal Symptom Score

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

  4 weeks

Secondary Outcomes (2)

• Change in Mean Nighttime Nasal Symptom from baseline at Weeks 1-2 (2 weeks) and Weeks 3-4 (2 weeks) of treatment

  4 weeks

• Mean Composite Symptom Score

  4 weeks

Study Arms (3)

Test arm

EXPERIMENTAL

Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg

Drug: Montelukast + Levocetirizine

Comparator arm I

ACTIVE COMPARATOR

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

Drug: Levocetirizine

Comparator arm II

ACTIVE COMPARATOR

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

Drug: Montelukast

Interventions

Montelukast + Levocetirizine DRUG

Tablet, Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime)

Also known as: Singulair Tablet, Xyzal Tablet

Test arm

Levocetirizine DRUG

Tablet, Matching placebo of Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime)

Also known as: Xyzal Tablet

Comparator arm I

Montelukast DRUG

Tablet, Montelukast sodium 10 mg + matching placebo of Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime)

Also known as: Singulair Tablet

Comparator arm II

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, 420-767, South Korea

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

montelukast; levocetirizine

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Kyungmi PARK, PhD

  Hanmi Pharmaceutical Company Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 13, 2012
• Study Start: June 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 8, 2013

Record last verified: 2013-04

Locations

KR (1)