This is a study to evaluate the efficacy and safety of grass sublingual tablet (SCH 697243) versus placebo in the treatment of grass pollen-induced allergic hayfever symptoms. Participants will receive either the sublingual grass tablet or a placebo tablet during the study. It is expected that those participants receiving the active sublingual grass tablet will have less hayfever symptoms and need less medications to treat hayfever symptoms during the grass pollen season.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,501
One dissolving tablet sublingually once daily
One dissolving tablet sublingually once daily
Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS)
The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications. For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.
Time frame: Entire GPS (expected average duration of 5 to 6 weeks)
Average Rhinoconjunctivitis DSS Over the Entire GPS
For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.
Time frame: Entire GPS (expected average duration of 5 to 6 weeks)
Average Total Combined Rhinoconjunctivitis DSS and Rhinoconjunctivitis DMS Over the Peak GPS
The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications. For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.
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Time frame: Peak GPS (expected average duration of 2 weeks)
Average Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities for Participants ≥12 Years of Age (RQLQ12+) Over the Peak GPS
The RQLQ12+ consists of 7 domains: Activities, Sleep, Non-Nose/Eye Symptoms, Practical Problems, Nasal Symptoms, Eye Symptoms, Emotional. Participants reflect on their experience over the previous 7 days and assess 28 items on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0-6 \[mean of all domain scores\]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis.
Time frame: Peak GPS (expected average duration of 2 weeks)
Average Rhinoconjunctivitis DMS Over the Entire GPS
For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.
Time frame: Entire GPS (expected average duration of 5 to 6 weeks)
Average Rhinoconjunctivitis DSS Over the Peak GPS
For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.
Time frame: Peak GPS (expected average duration of 2 weeks)
Average Rhinoconjunctivitis DMS Over the Peak GPS
For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.
Time frame: Peak GPS (expected average duration of 2 weeks)
Average Paediatric Standardised Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score Over the Peak GPS (Participants 6 to <12 Years of Age)
For PRQLQ, participants assessed a total of 19 items within 5 domains: Nose Symptoms, Eye Symptoms, Practical Problems, Activity Limitation and Other Symptoms, each on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0 to 6 \[mean of all domain scores\]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis.
Time frame: Peak GPS (expected average duration of 2 weeks)