A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis

Phase 3

Completed

Conditions: Allergy

Interventions: Drug: Placebo
Drug: 5-grass mix SLIT-drops

Registration Number: NCT04881461

Lead Sponsor: ALK-Abelló A/S

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 445

Inclusion Criteria

Male or female aged ≥18 years on the day informed consent is obtained
A clinical history of grass pollen-induced allergic rhinoconjunctivitis for two years or more with or without asthma
A clinical history of severe allergic rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep) induced by grass pollen, which remain troublesome despite symptomatic treatment with antihistamines, nasal steroids or eye drops during the previous grass pollen season
Positive specific immunoglobulin E (IgE) (defined as ≥class 2, ≥0.70 kU/l) against grass: Phleum pratense
Positive skin prick test to Phleum pratense at screening

Exclusion Criteria

Has a clinically relevant history of symptomatic seasonal and/or perennial allergic rhinoconjunctivitis and/or asthma caused by an allergen other than grass pollen, to which the subject is exposed, which could potentially overlap with the efficacy assessment periods
Within the last 3 months before the randomisation visit, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
SLIT treatment with any grass pollen AIT for more than 1 month within the last 5 years. In addition, any SLIT treatment with grass pollen AIT within the previous 12 months
SCIT treatment with any grass AIT reaching the maintenance dose within the last 5 years. In addition, any SCIT treatment with grass AIT within the previous 12 months
Ongoing treatment with any allergy immunotherapy product
Uncontrolled or severe asthma requiring daily use of more than 800 mcg budesonide or equivalent at screening

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Glycerol, carbonate, sodium chloride One single-dose container (0.5 ml) once daily
5-grass mix SLIT-drops	5-grass mix SLIT-drops	Grass mix sublingual allergy immunotherapy drops One single-dose container (0.5 ml) once daily. 50 SRU/day for five consecutive days followed by 150 SRU/day for five additional consecutive days. Maintenance: 300 SRU/day from day 11.

Primary Outcome Measures

Name	Time	Method
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Peak Grass Pollen Season (PGPS)	During the 2nd PGPS (14 days)	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.

Secondary Outcome Measures

Name	Time	Method
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Peak Grass Pollen Season (PGPS)	During the 2nd PGPS (14 days)	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.
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 2nd Entire Grass Pollen Season (EGPS)	During the 2nd EGPS (observed mean duration of approximately 9 weeks)	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.
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Entire Grass Pollen Season (EGPS)	During the 1st EGPS (observed mean duration of approximately 8 weeks)	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.
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Entire Grass Pollen Season (EGPS)	During the 2nd EGPS (observed mean duration of approximately 9 weeks)	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.
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Peak Grass Pollen Season (PGPS)	During the 1st PGPS (14 days)	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.
Average Weekly Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score During the 1st Entire Grass Pollen Season (EGPS)	During the 1st EGPS (observed mean duration of approximately 8 weeks)	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.
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Peak Grass Pollen Season (PGPS)	During the 1st PGPS (14 days)	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.
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Peak Grass Pollen Season (PGPS)	During the 2nd PGPS (14 days)	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.
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 1st Entire Grass Pollen Season (EGPS)	During the 1st EGPS (observed mean duration of approximately 8 weeks)	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.
Average Allergic Rhinoconjunctivitis Daily Symptoms Score (DSS) During the 2nd Entire Grass Pollen Season (EGPS)	During the 2nd EGPS (observed mean duration of approximately 9 weeks)	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.
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Peak Grass Pollen Season (PGPS)	During the 1st PGPS (14 days)	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.
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 1st Entire Grass Pollen Season (EGPS)	During the 1st EGPS (observed mean duration of approximately 8 weeks)	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.
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Peak Grass Pollen Season (PGPS)	During the 2nd PGPS (14 days)	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.
Average Allergic Rhinoconjunctivitis Daily Medication Score (DMS) During the 2nd Entire Grass Pollen Season (EGPS)	During the 2nd EGPS (observed mean duration of approximately 9 weeks)	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.
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 1st Peak Grass Pollen Season (PGPS)	During the 1st PGPS (14 days)	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.

Trial Locations

Locations (44): Fakultni Nemocnice u Sv. Anny - FNUSA
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Brno, Czechia
Alergopraktik s.r.o.
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Jablonec Nad Nisou, Czechia
Allergology Jihlava
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Jihlava, Czechia
Alergologicka Ambulance - Liberec
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Liberec, Czechia
Alergomyšl s.r.o
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Litomyšl, Czechia
Acredula Benedicta s.r.o.
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Pardubice, Czechia
MUJ ALERGOLOG s.r.o.
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Trutnov, Czechia
KASMED s.r.o.
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Tábor, Czechia
Ambulance alergologie a klinicke imunologie - Ceske Budejovice
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České Budějovice, Czechia
North Estonia Medical Centre Foundation
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Tallinn, Estonia
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Fakultni Nemocnice u Sv. Anny - FNUSA
🇨🇿Brno, Czechia