Seasonal Allergic Rhinitis
Conditions
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.
Interventions
DRUGMontelukast
Montelukast 5 mg chewable tablets, taken orally once daily at bedtime for 7 days
DRUGPlacebo
Matching placebo chewable tablets, taken orally once daily at bedtime for 7 days
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to 15 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 110 |
| 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. | 110 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | Montelukast/Placebo | Placebo/Montelukast | Total |
|---|---|---|---|
| Age, Continuous | 12.3 years STANDARD_DEVIATION 1.6 | 12.7 years STANDARD_DEVIATION 1.5 | 12.5 years STANDARD_DEVIATION 1.6 |
| Sex: Female, Male Female | 55 Participants | 59 Participants | 114 Participants |
| Sex: Female, Male Male | 55 Participants | 51 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 216 | 17 / 218 |
| serious Total, serious adverse events | 0 / 216 | 0 / 218 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Montelukast | Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure | 1.17 score on a scale |
| Placebo | Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure | 1.18 score on a scale |
p-value: 0.91395% CI: [-0.11, 0.1]Longitudinal Data Analysis (LDA)
Primary
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Montelukast | Percentage of Participants Who Experience at Least One Adverse Event | 10.2 percentage of participants |
| Placebo | Percentage of Participants Who Experience at Least One Adverse Event | 16.5 percentage of participants |
Secondary
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.
Time frame: Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Montelukast | Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 30 minutes after entering chamber room | 0.32 score on a scale |
| Montelukast | Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 90 minutes after entering chamber room | 0.74 score on a scale |
| Montelukast | Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 180 minutes after entering chamber room | 0.83 score on a scale |
| Montelukast | Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 120 minutes after entering chamber room | 0.80 score on a scale |
| Montelukast | Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 60 minutes after entering chamber room | 0.55 score on a scale |
| Montelukast | Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 150 minutes after entering chamber room | 0.83 score on a scale |
| Placebo | Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 180 minutes after entering chamber room | 0.81 score on a scale |
| Placebo | Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 150 minutes after entering chamber room | 0.81 score on a scale |
| Placebo | Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 30 minutes after entering chamber room | 0.33 score on a scale |
| Placebo | Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 60 minutes after entering chamber room | 0.56 score on a scale |
| Placebo | Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 90 minutes after entering chamber room | 0.73 score on a scale |
| Placebo | Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 120 minutes after entering chamber room | 0.82 score on a scale |
Secondary
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.
Time frame: Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Montelukast | Change From Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure | 0.68 score on a scale |
| Placebo | Change From Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure | 0.68 score on a scale |
p-value: 0.97495% CI: [-0.07, 0.07]LDA
Secondary
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.
Time frame: Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Montelukast | Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 90 minutes after entering chamber room | 0.39 score on a scale |
| Montelukast | Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 30 minutes after entering chamber room | 0.13 score on a scale |
| Montelukast | Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 180 minutes after entering chamber room | 0.33 score on a scale |
| Montelukast | Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 60 minutes after entering chamber room | 0.27 score on a scale |
| Montelukast | Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 120 minutes after entering chamber room | 0.34 score on a scale |
| Montelukast | Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 150 minutes after entering chamber room | 0.31 score on a scale |
| Placebo | Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 180 minutes after entering chamber room | 0.37 score on a scale |
| Placebo | Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 90 minutes after entering chamber room | 0.38 score on a scale |
| Placebo | Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 120 minutes after entering chamber room | 0.36 score on a scale |
| Placebo | Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 150 minutes after entering chamber room | 0.32 score on a scale |
| Placebo | Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 60 minutes after entering chamber room | 0.33 score on a scale |
| Placebo | Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 30 minutes after entering chamber room | 0.17 score on a scale |
Secondary
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.
Time frame: Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Montelukast | Change From Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure | 0.29 score on a scale |
| Placebo | Change From Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure | 0.32 score on a scale |
p-value: 0.18295% CI: [-0.06, 0.01]LDA
Secondary
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.
Time frame: Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Montelukast | Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 30 minutes after entering chamber room | 0.09 score on a scale |
| Montelukast | Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 60 minutes after entering chamber room | 0.18 score on a scale |
| Montelukast | Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 90 minutes after entering chamber room | 0.23 score on a scale |
| Montelukast | Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 120 minutes after entering chamber room | 0.25 score on a scale |
| Montelukast | Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 150 minutes after entering chamber room | 0.24 score on a scale |
| Montelukast | Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 180 minutes after entering chamber room | 0.23 score on a scale |
| Placebo | Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 150 minutes after entering chamber room | 0.21 score on a scale |
| Placebo | Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 30 minutes after entering chamber room | 0.09 score on a scale |
| Placebo | Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 120 minutes after entering chamber room | 0.17 score on a scale |
| Placebo | Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 60 minutes after entering chamber room | 0.18 score on a scale |
| Placebo | Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 180 minutes after entering chamber room | 0.23 score on a scale |
| Placebo | Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 90 minutes after entering chamber room | 0.20 score on a scale |
Secondary
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.
Time frame: Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Montelukast | Change From Baseline in Sneezing Score Averaged During 3 Hours of Exposure | 0.20 score on a scale |
| Placebo | Change From Baseline in Sneezing Score Averaged During 3 Hours of Exposure | 0.18 score on a scale |
p-value: 0.16195% CI: [-0.01, 0.05]LDA
Secondary
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.
Time frame: Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Montelukast | Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 30 minutes after entering chamber room | 0.54 score on a scale |
| Montelukast | Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 60 minutes after entering chamber room | 1.00 score on a scale |
| Montelukast | Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 90 minutes after entering chamber room | 1.36 score on a scale |
| Montelukast | Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 120 minutes after entering chamber room | 1.38 score on a scale |
| Montelukast | Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 150 minutes after entering chamber room | 1.38 score on a scale |
| Montelukast | Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 180 minutes after entering chamber room | 1.39 score on a scale |
| Placebo | Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 150 minutes after entering chamber room | 1.35 score on a scale |
| Placebo | Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 30 minutes after entering chamber room | 0.59 score on a scale |
| Placebo | Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 120 minutes after entering chamber room | 1.35 score on a scale |
| Placebo | Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 60 minutes after entering chamber room | 1.07 score on a scale |
| Placebo | Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 180 minutes after entering chamber room | 1.40 score on a scale |
| Placebo | Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 90 minutes after entering chamber room | 1.31 score on a scale |
Secondary
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.
Time frame: Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Montelukast | Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 60 minutes after entering chamber room | 1.55 score on a scale |
| Montelukast | Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 90 minutes after entering chamber room | 2.11 score on a scale |
| Montelukast | Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 120 minutes after entering chamber room | 2.17 score on a scale |
| Montelukast | Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 150 minutes after entering chamber room | 2.21 score on a scale |
| Montelukast | Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 30 minutes after entering chamber room | 0.86 score on a scale |
| Montelukast | Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 180 minutes after entering chamber room | 2.22 score on a scale |
| Placebo | Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 30 minutes after entering chamber room | 0.91 score on a scale |
| Placebo | Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 60 minutes after entering chamber room | 1.63 score on a scale |
| Placebo | Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 150 minutes after entering chamber room | 2.16 score on a scale |
| Placebo | Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 90 minutes after entering chamber room | 2.04 score on a scale |
| Placebo | Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 180 minutes after entering chamber room | 2.21 score on a scale |
| Placebo | Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room | 120 minutes after entering chamber room | 2.17 score on a scale |
Secondary
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.
Time frame: Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Montelukast | Change From Baseline in Weighted TNSS Averaged During 3 Hours of Exposure | 1.85 score on a scale |
| Placebo | Change From Baseline in Weighted TNSS Averaged During 3 Hours of Exposure | 1.86 score on a scale |
p-value: 0.95395% CI: [-0.17, 0.16]LDA