A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised, Parallel-group, Double-blind, Placebo-controlled Phase III Trial Assessing the Efficacy and Safety of 5-grass Mix SLIT-drops in Adults With Grass Pollen-induced Rhinoconjunctivitis

Conditions
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Allergy

Intervention / Treatment
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* Drug: 5-grass mix SLIT-drops
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Glycerol, carbonate, sodium chloride One single-dose container (0.5 ml) once daily | Drug: Placebo<br>* Placebo<br>|
| Experimental: 5-grass mix SLIT-drops<br>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. | Drug: 5-grass mix SLIT-drops<br>* Sublingual allergy immunotherapy drops, for daily administration<br>* Other names: SLIToneULTRA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average daily allergic rhinoconjunctivitis total combined score (TCS) during the 2nd PGPS (Peak Grass Pollen Season) | TCS is the sum of the allergic rhinoconjunctivitis DSS and the allergic rhinoconjunctivitis DMS. DSS, corresponds to a sum of 6 individual symptom scores: runny nose, nasal congestion (blocked nose), sneezing, itchy nose, itchy eyes (gritty feeling, red eyes), and watery eyes. Each symptom will be scored with the following values: no symptoms (0 points), mild symptoms (1 point), moderate symptoms (2 points), or severe symptoms (3 points). Thus, the maximum daily symptom score will be 18. DMS, is based on use according to the need of the symptom relieving medications used. Each dose of medication has a score between 1.5 and 6 (tablet score of 6, nasal spray score of 2 and eye drops score of 1.5 per eye). Maximum daily score is 6, 8 and 6 respectively and the maximum daily score is 20. The higher scores the more symptoms. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average score of weekly overall rhinitis quality of life questionnaire (RQLQ) during the 2nd PGPS (Peak Grass Pollen Season) | Rhinitis Quality of Life questionnaire. RQLQ questionnaire contains 28 questions that are scored in 7-point scale (0 = not impaired at all; 6 = severely impaired). Questions are divided in 7 domains (activity limitations). The overall RQLQ score a mean of 27 questions. The higher scores the more symptoms. | 6 months | 
| Average daily allergic rhinoconjunctivitis TCS during the 1st PGPS (Peak Grass Pollen Season) | TCS is the sum of the allergic rhinoconjunctivitis DSS and the allergic rhinoconjunctivitis DMS. DSS, corresponds to a sum of 6 individual symptom scores: runny nose, nasal congestion (blocked nose), sneezing, itchy nose, itchy eyes (gritty feeling, red eyes), and watery eyes. Each symptom will be scored with the following values: no symptoms (0 points), mild symptoms (1 point), moderate symptoms (2 points), or severe symptoms (3 points). Thus, the maximum daily symptom score will be 18. DMS will be based on use according to the need of the rescue medications - scores between 0-20 (The higher values the more rescue medication needed). | 6 months | 
| Average score of weekly overall RQLQ during the 1st PGPS (Peak Grass Pollen Season) | Rhinitis Quality of Life questionnaire. RQLQ questionnaire contains 28 questions that are scored in 7-point scale (0 = not impaired at all; 6 = severely impaired). Questions are divided in 7 domains (activity limitations). The overall RQLQ score a mean of 27 questions. The higher scores the more symptoms. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic rhinoconjunctivitis, Adults, Grass