Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519)

A Phase III, Double-Blind, Randomized, Placebo-Controlled Cross-over Clinical Trial to Study the Efficacy and Safety of MK-0476 in Japanese Pediatric Subjects With Seasonal Allergic Rhinitis

This study will evaluate the efficacy and safety of montelukast (MK-0476) in the treatment of Japanese pediatric participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that montelukast is superior to placebo in the treatment of nasal symptoms in SAR.

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: Montelukast; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Weight: ≥ 25 kg
• Height: ≥ 125 cm
• Able to record symptoms in a diary
• Has had allergic rhinitis symptoms [Japanese Cedar (JC) pollinosis]
• Tested positive for JC pollen specific immunoglobulin E (IgE) antibody assay

Exclusion Criteria:

• Has nasal findings that would interfere with evaluating nasal congestion symptoms
• Past or present medical history of bronchial asthma
• Medical history of allergies except allergic rhinitis and has possibility of dramatically worsening of these symptoms induced by JC pollen exposure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Montelukast/Placebo; Participants receive montelukast 5 mg chewable tablets for 7 days during Period 1 and receive placebo chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.	Drug: Montelukast; Montelukast 5 mg chewable tablets, taken orally once daily at bedtime for 7 days; Other Names: montelukast sodium; Drug: Placebo; Matching placebo chewable tablets, taken orally once daily at bedtime for 7 days
Experimental: Placebo/Montelukast; Participants receive placebo chewable tablets for 7 days during Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.	Drug: Montelukast; Montelukast 5 mg chewable tablets, taken orally once daily at bedtime for 7 days; Other Names: montelukast sodium; Drug: Placebo; Matching placebo chewable tablets, taken orally once daily at bedtime for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure	The TNSS is the sum of the three nasal symptom scores for nasal congestion, nasal discharge and sneezing. Participants completed a questionnaire about their nasal symptoms. Score ranged from 0 to 4 for each of the three nasal symptoms, with a total possible score ranging from 0 to 12 and a higher score indicating more severe nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period during 3 hours of exposure to Japanes cedar (JC) pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
Percentage of Participants Who Experience at Least One Adverse Event	An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence adverse events for up to 14 days after last dose of study drug. Analysis was done by study drug as taken.	Up to 5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Weighted TNSS Averaged During 3 Hours of Exposure	TNSS was weighted as 2:1:1 for nasal congestion, nasal discharge and sneezing. The Weighted TNSS ranged from 0 to 16, with a higher score indicating more severe weighted total nasal symptoms. The baseline Weighted TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
Change From Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure	The Nasal Congestion Score was assessed as 0 = No symptoms of nasal congestion to 4 = Completely obstructed all day, with a possible Nasal Congestion Score ranging from 0 to 4 and a higher score indicating more severe nasal congestion. The baseline Nasal Congestion Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Nasal Congestion Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
Change From Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure	The Nasal Discharge Score was assessed as 0 = 0 times participant blew his/her nose to 4 = 21 or more times participant blew his/her nose, with a possible Nasal Discharge Score ranging from 0 to 4 and a higher score indicating more severe nasal discharge. The baseline Nasal Discharge Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Nasal Discharge Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
Change From Baseline in Sneezing Score Averaged During 3 Hours of Exposure	The Sneezing Score was assessed as 0 = 0 times participant sneezed to 4 = 21 or more times participant sneezed, with a possible Sneezing Score ranging from 0 to 4 and a higher score indicating more severe sneezing. The baseline Sneezing Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Sneezing Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room	The TNSS is the sum of the three nasal symptom scores for nasal congestion, nasal discharge and sneezing. The possible TNSS ranged from 0 to 12, with a higher score indicting more severe total nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.	Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period
Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room	TNSS was weighted as 2:1:1 for nasal congestion, nasal discharge and sneezing. The possible Weighted TNSS ranged from 0 to 16, with a higher score indicating more severe total nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Weighted TNSS was assessed on Day 7 of a treatment period at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.	Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period
Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room	The Nasal Congestion Score was assessed as 0 = No symptoms of nasal congestion to 4 = Completely obstructed all day. The possible Nasal Congestion Score ranged from 0 to 4, with a higher score indicating more severe nasal congestion.The Nasal Congestion Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.	Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period
Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room	The Nasal Discharge Score was assessed as 0 = 0 times participant blew his/her nose to 4 = 21 or more times participant blew his/her nose. The possible Nasal Discharge Score ranged from 0 to 4, with a higher score indicating more severe nasal discharge.The Nasal Discharge Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.	Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period
Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room	The Sneezing Score was assessed as 0 = 0 times participant sneezed to 4 = 21 or more times participant sneezed. The possible Sneezing Score ranged from 0 to 4, with a higher score indicating more severe sneezing. The Sneezing Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.	Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Hashiguchi K, Okubo K, Inoue Y, Numaguchi H, Tanaka K, Oshima N, Mehta A, Nishida C, Saito I, Philip G. Evaluation of Montelukast for the Treatment of Children With Japanese Cedar Pollinosis Using an Artificial Exposure Chamber (OHIO Chamber). Allergy Rhinol (Providence). 2018 Jul 13;9:2152656718783599. doi: 10.1177/2152656718783599. eCollection 2018 Jan-Dec. Erratum In: Allergy Rhinol (Providence). 2018 Aug 22;9:2152656718797803.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: May 16, 2013
• First Submitted That Met QC Criteria: May 16, 2013
• First Posted (Estimated): May 20, 2013

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: 0476-519; 132232 (Registry Identifier: JAPIC-CTI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Study Data/Documents

1. CSR Synopsis