This is a 2 year clinical study to compare 5-grass mix SLIT-drops with placebo in relieving grass pollen-induced rhinoconjunctivitis symptoms and in use of symptom-relieving medication during the second grass pollen season (peak grass pollen season, PGPS) The study will collect health-related quality of life data in the groups treated with 5-grass mix SLIT-drops or with placebo during the first and second PGPS. The trial medication used is already approved to treat allergic rhinitis caused by grass pollen in adults in several countries.
This trial is a 2 year, parallel-group, double-blind, placebo-controlled phase III trial to evaluate efficacy and safety of the 5-grass mix SLIT-drops in adults with grass pollen-induced rhinoconjunctivitis with or without asthma. Approximately 440 adults will be enrolled in the trial and will receive the 5-grass mix SLIT-drops or placebo. The trial is conducted in several European countries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
445
Sublingual allergy immunotherapy drops, for daily administration
Placebo
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Peak Grass Pollen Season (PGPS)
The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.
Time frame: During the 2nd PGPS (14 days)
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Peak Grass Pollen Season (PGPS)
The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 2nd PGPS.
Time frame: During the 2nd PGPS (14 days)
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Peak Grass Pollen Season (PGPS)
The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS.
Time frame: During the 1st PGPS (14 days)
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Peak Grass Pollen Season (PGPS)
The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 1st PGPS.
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České Budějovice, Czechia
Alergopraktik s.r.o.
Jablonec nad Nisou, Czechia
Allergology Jihlava
Jihlava, Czechia
Alergologicka Ambulance - Liberec
Liberec, Czechia
Alergomyšl s.r.o
Litomyšl, Czechia
Acredula Benedicta s.r.o.
Pardubice, Czechia
KASMED s.r.o.
Tábor, Czechia
MUJ ALERGOLOG s.r.o.
Trutnov, Czechia
North Estonia Medical Centre Foundation
Tallinn, Estonia
...and 38 more locations
Time frame: During the 1st PGPS (14 days)
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Entire Grass Pollen Season (EGPS)
The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 1st EGPS.
Time frame: During the 1st EGPS (observed mean duration of approximately 8 weeks)
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Entire Grass Pollen Season (EGPS)
The RQLQ measures the rhinoconjunctivitis quality of life. The RQLQ contains 28 questions, each scored on a 7-point scale (0 = not impaired at all; 6 = severely impaired). The overall RQLQ score is a mean of the 28 questions. Higher scores indicate worse quality of life. The endpoint is calculated as the average score of all reported weekly values during the 2nd EGPS.
Time frame: During the 2nd EGPS (observed mean duration of approximately 9 weeks)
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Entire Grass Pollen Season (EGPS)
The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS.
Time frame: During the 1st EGPS (observed mean duration of approximately 8 weeks)
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Entire Grass Pollen Season (EGPS)
The average daily TCS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms and in use of symptom-relieving medication (on a scale from 0 to 38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS.
Time frame: During the 2nd EGPS (observed mean duration of approximately 9 weeks)
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Peak Grass Pollen Season (PGPS)
The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS.
Time frame: During the 1st PGPS (14 days)
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Peak Grass Pollen Season (PGPS)
The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.
Time frame: During the 2nd PGPS (14 days)
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Entire Grass Pollen Season (EGPS)
The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS.
Time frame: During the 1st EGPS (observed mean duration of approximately 8 weeks)
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Entire Grass Pollen Season (EGPS)
The average DSS evaluates the treatment effect based on reduction in daily rhinoconjunctivitis symptoms (on a scale from 0 to18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS.
Time frame: During the 2nd EGPS (observed mean duration of approximately 9 weeks)
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Peak Grass Pollen Season (PGPS)
The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st PGPS.
Time frame: During the 1st PGPS (14 days)
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Peak Grass Pollen Season (PGPS)
The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale of 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd PGPS.
Time frame: During the 2nd PGPS (14 days)
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Entire Grass Pollen Season (EGPS)
The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication(on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 1st EGPS.
Time frame: During the 1st EGPS (observed mean duration of approximately 8 weeks)
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Entire Grass Pollen Season (EGPS)
The average DMS evaluates the treatment effect based on reduction in daily use of rhinoconjunctivitis symptom-relieving medication (on a scale from 0 to 20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 2nd EGPS.
Time frame: During the 2nd EGPS (observed mean duration of approximately 9 weeks)