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

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01857063
• Collaborator: (none)
• Enrollment: 220
• Arms: 2
• Actual Duration (Months): 2.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Seasonal Allergic Rhinitis	Drug: Montelukast; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 220 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Jun 10, 2013
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure [Baseline and after 3 hours of pollen exposure on Day 7 of each 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.

2. Percentage of Participants Who Experience at Least One Adverse Event [Up to 5 weeks]

   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.

Secondary Outcome Measures

1. Change From Baseline in Weighted TNSS Averaged During 3 Hours of Exposure [Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period]

   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.

2. Change From Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure [Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period]

   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.

3. Change From Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure [Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period]

   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.

4. Change From Baseline in Sneezing Score Averaged During 3 Hours of Exposure [Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period]

   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.

5. Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room [Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period]

   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.

6. Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room [Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period]

   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.

7. Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room [Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period]

   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.

8. Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room [Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period]

   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.

9. Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room [Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT01857063
• Other Study ID Numbers: 0476-519; 132232
• First Posted: May 20, 2013
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Montelukast

Study Results

Participant Flow

Arm/Group Title	Montelukast/Placebo	Placebo/Montelukast
Arm/Group Description	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.	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 Title: Period 1 (7 Days)
STARTED	110	110
COMPLETED	108	106
NOT COMPLETED	2	4
Period Title: Period 1 (7 Days)
STARTED	108	106
COMPLETED	104	104
NOT COMPLETED	4	2

Baseline Characteristics

Arm/Group Title	Montelukast/Placebo	Placebo/Montelukast	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	110	110	220
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	12.3 (1.6)	12.7 (1.5)	12.5 (1.6)
Sex: Female, Male (Count of Participants)
Female	55 50%	59 53.6%	114 51.8%
Male	55 50%	51 46.4%	106 48.2%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure
Description	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.
Time Frame	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Montelukast	Placebo
Arm/Group Description	Participants receive montelukast 5 mg for 7 days, regardless of sequence.	Participants receive placebo for 7 days, regardless of sequence.
Measure Participants	213	211
Least Squares Mean (95% Confidence Interval) [score on a scale]	1.17	1.18

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Montelukast, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.913
	Comments	Longitudinal Data Analysis (LDA) model with baseline TNSS as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.
	Method	Longitudinal Data Analysis (LDA)
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares (LS) Means
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 95%; -0.11 to 0.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Percentage of Participants Who Experience at Least One Adverse Event
Description	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.
Time Frame	Up to 5 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Montelukast	Placebo
Arm/Group Description	Participants receive montelukast 5 mg for 7 days, regardless of sequence.	Participants receive placebo for 7 days, regardless of sequence.
Measure Participants	216	218
Number [percentage of participants]	10.2 9.3%	16.5 15%

3. Secondary Outcome

Title	Change From Baseline in Weighted TNSS Averaged During 3 Hours of Exposure
Description	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.
Time Frame	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period

Outcome Measure Data

Analysis Population Description

The 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.

Arm/Group Title	Montelukast	Placebo
Arm/Group Description	Participants receive montelukast 5 mg for 7 days, regardless of sequence.	Participants receive placebo for 7 days, regardless of sequence.
Measure Participants	213	211
Least Squares Mean (95% Confidence Interval) [score on a scale]	1.85	1.86

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Montelukast, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.953
	Comments	Longitudinal Data Analysis (LDA) model with baseline Weighted TNSS as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.
	Method	LDA
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-0.00
	Confidence Interval	(2-Sided) 95%; -0.17 to 0.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure
Description	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.
Time Frame	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period

Outcome Measure Data

Analysis Population Description

The 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.

Arm/Group Title	Montelukast	Placebo
Arm/Group Description	Participants receive montelukast 5 mg for 7 days, regardless of sequence.	Participants receive placebo for 7 days, regardless of sequence.
Measure Participants	213	211
Least Squares Mean (95% Confidence Interval) [score on a scale]	0.68	0.68

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Montelukast, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.974
	Comments	Longitudinal Data Analysis (LDA) model with baseline nasal congestion score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.
	Method	LDA
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-0.00
	Confidence Interval	(2-Sided) 95%; -0.07 to 0.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Change From Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure
Description	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.
Time Frame	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period

Outcome Measure Data

Analysis Population Description

The 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.

Arm/Group Title	Montelukast	Placebo
Arm/Group Description	Participants receive montelukast 5 mg for 7 days, regardless of sequence.	Participants receive placebo for 7 days, regardless of sequence.
Measure Participants	213	211
Least Squares Mean (95% Confidence Interval) [score on a scale]	0.29	0.32

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Montelukast, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.182
	Comments	Longitudinal Data Analysis (LDA) model with baseline nasal discharge score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.
	Method	LDA
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 95%; -0.06 to 0.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline in Sneezing Score Averaged During 3 Hours of Exposure
Description	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.
Time Frame	Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period

Outcome Measure Data

Analysis Population Description

The 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.

Arm/Group Title	Montelukast	Placebo
Arm/Group Description	Participants receive montelukast 5 mg for 7 days, regardless of sequence.	Participants receive placebo for 7 days, regardless of sequence.
Measure Participants	213	211
Least Squares Mean (95% Confidence Interval) [score on a scale]	0.20	0.18

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Montelukast, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.161
	Comments	Longitudinal Data Analysis (LDA) model with baseline sneezing score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.
	Method	LDA
	Comments
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95%; -0.01 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
Description	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.
Time Frame	Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period

Outcome Measure Data

Analysis Population Description

The 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.

Arm/Group Title	Montelukast	Placebo
Arm/Group Description	Participants receive montelukast 5 mg for 7 days, regardless of sequence.	Participants receive placebo for 7 days, regardless of sequence.
Measure Participants	213	211
30 minutes after entering chamber room	0.54	0.59
60 minutes after entering chamber room	1.00	1.07
90 minutes after entering chamber room	1.36	1.31
120 minutes after entering chamber room	1.38	1.35
150 minutes after entering chamber room	1.38	1.35
180 minutes after entering chamber room	1.39	1.40

8. Secondary Outcome

Title	Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
Description	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.
Time Frame	Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period

Outcome Measure Data

Analysis Population Description

The 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.

Arm/Group Title	Montelukast	Placebo
Arm/Group Description	Participants receive montelukast 5 mg for 7 days, regardless of sequence.	Participants receive placebo for 7 days, regardless of sequence.
Measure Participants	213	211
30 minutes after entering chamber room	0.86	0.91
60 minutes after entering chamber room	1.55	1.63
90 minutes after entering chamber room	2.11	2.04
120 minutes after entering chamber room	2.17	2.17
150 minutes after entering chamber room	2.21	2.16
180 minutes after entering chamber room	2.22	2.21

9. Secondary Outcome

Title	Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
Description	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.
Time Frame	Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period

Outcome Measure Data

Analysis Population Description

The 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.

Arm/Group Title	Montelukast	Placebo
Arm/Group Description	Participants receive montelukast 5 mg for 7 days, regardless of sequence.	Participants receive placebo for 7 days, regardless of sequence.
Measure Participants	213	211
30 minutes after entering chamber room	0.32	0.33
60 minutes after entering chamber room	0.55	0.56
90 minutes after entering chamber room	0.74	0.73
120 minutes after entering chamber room	0.80	0.82
150 minutes after entering chamber room	0.83	0.81
180 minutes after entering chamber room	0.83	0.81

10. Secondary Outcome

Title	Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
Description	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.
Time Frame	Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period

Outcome Measure Data

Analysis Population Description

The 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.

Arm/Group Title	Montelukast	Placebo
Arm/Group Description	Participants receive montelukast 5 mg for 7 days, regardless of sequence.	Participants receive placebo for 7 days, regardless of sequence.
Measure Participants	213	211
30 minutes after entering chamber room	0.13	0.17
60 minutes after entering chamber room	0.27	0.33
90 minutes after entering chamber room	0.39	0.38
120 minutes after entering chamber room	0.34	0.36
150 minutes after entering chamber room	0.31	0.32
180 minutes after entering chamber room	0.33	0.37

11. Secondary Outcome

Title	Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
Description	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.
Time Frame	Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period

Outcome Measure Data

Analysis Population Description

The 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.

Arm/Group Title	Montelukast	Placebo
Arm/Group Description	Participants receive montelukast 5 mg for 7 days, regardless of sequence.	Participants receive placebo for 7 days, regardless of sequence.
Measure Participants	213	211
30 minutes after entering chamber room	0.09	0.09
60 minutes after entering chamber room	0.18	0.18
90 minutes after entering chamber room	0.23	0.20
120 minutes after entering chamber room	0.25	0.17
150 minutes after entering chamber room	0.24	0.21
180 minutes after entering chamber room	0.23	0.23

Adverse Events

Time Frame	Up to 14 days after last dose of study drug (Up to 5 weeks)
Adverse Event Reporting Description	The All Patients as Treated (APaT) population consisted of all randomized participants who received at least one dose of study drug.
Arm/Group Title	Montelukast		Placebo
Arm/Group Description	Participants receive montelukast 5 mg for 7 days, regardless of sequence.		Participants receive placebo for 7 days, regardless of sequence.
All Cause Mortality
	Montelukast		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Montelukast		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/216 (0%)		0/218 (0%)
Other (Not Including Serious) Adverse Events
	Montelukast		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/216 (4.6%)		17/218 (7.8%)
Investigations
Protein urine present	10/216 (4.6%)	10	17/218 (7.8%)	17

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.