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

Perennial Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01640535
• Other study ID #: HM-MOLZ-301
• Status: Completed
• Phase: Phase 3
• First received: July 10, 2012
• Last updated: April 4, 2013
• Start date: June 2012
• Est. completion date: February 2013

Study information

• Verified date: April 2013
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Daytime Nasal Symptom Score	Change in Mean Daytime Nasal Symptom Score from baseline at Weeks 3-4(2 weeks) of treatment	4 weeks	No
Secondary	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	4 weeks	No
Secondary	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	4 weeks	No