Trial Outcomes & Findings for Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519) (NCT NCT01857063)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

220 participants

Primary outcome timeframe

Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period

Results posted on

2024-06-17

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Period 1 (7 Days) STARTED	110	110
Period 1 (7 Days) COMPLETED	108	106
Period 1 (7 Days) NOT COMPLETED	2	4
Period 2 (7 Days) STARTED	108	106
Period 2 (7 Days) COMPLETED	104	104
Period 2 (7 Days) NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Period 1 (7 Days) Adverse Event	0	1
Period 1 (7 Days) Physician Decision	1	0
Period 1 (7 Days) Withdrawal by Subject	1	3
Period 2 (7 Days) Adverse Event	2	1
Period 2 (7 Days) Physician Decision	1	1
Period 2 (7 Days) Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Montelukast/Placebo n=110 Participants 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.	Placebo/Montelukast n=110 Participants 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.	Total n=220 Participants Total of all reporting groups
Age, Continuous	12.3 years STANDARD_DEVIATION 1.6 • n=5 Participants	12.7 years STANDARD_DEVIATION 1.5 • n=7 Participants	12.5 years STANDARD_DEVIATION 1.6 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	59 Participants n=7 Participants	114 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	51 Participants n=7 Participants	106 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period

Population: The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.

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.

Outcome measures

Outcome measures
Measure	Montelukast n=213 Participants Participants receive montelukast 5 mg for 7 days, regardless of sequence.	Placebo n=211 Participants Participants receive placebo for 7 days, regardless of sequence.
Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure	1.17 score on a scale Interval 1.03 to 1.31	1.18 score on a scale Interval 1.04 to 1.32

PRIMARY outcome

Timeframe: Up to 5 weeks

Population: The All Patients as Treated (APaT) population consisted of all randomized participants who received at least one dose of study drug.

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.