Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage

Official Title
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Randomised,Double-blind,Placebo-controlled,Multinational,Multi-centre,Phase IIb/III Study of the Efficacy and Safety of Three Doses of Sublingual Immunotherapy (SLIT) Administered as Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis

Conditions
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Allergy

Intervention / Treatment
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* Drug: 100 IR grass pollen allergen extract tablet
* Drug: 300 IR grass pollen allergen extract tablet
* Drug: 500 IR grass pollen allergen extract tablet
* Drug: Placebo tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written consent Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons. Sensitised to grass pollen (positive SPT and RAST level of at least class 2). Total symptom score of the RRTSS during the previous pollen season greater than or equal to 12. Safety laboratory resuts within the references ranges Exclusion Criteria: Pregnancy, breast-feeding/lactation Had received desensitisation treatment for grass pollen Treatment by immunotherapy with another allergen within the previous 5 years Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies Treated with beta-blockers or under continuous corticotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Experimental: 100 IR<br>100 IR grass pollen allergen extract tablet | Drug: 100 IR grass pollen allergen extract tablet<br>* One sublingual tablet daily during 4 months before pollen season and during pollen season<br>* Other names: Sublingual immunotherapy tablet;|
| Experimental: 300 IR<br>300 IR grass pollen allergen extract tablet | Drug: 300 IR grass pollen allergen extract tablet<br>* One sublingual tablet daily during 4 months before pollen season and during pollen season<br>* Other names: Sublingual immunotherapy tablet;|
| Experimental: 500 IR<br>500 IR grass pollen allergen extract tablet | Drug: 500 IR grass pollen allergen extract tablet<br>* One sublingual tablet daily during 4 months before pollen season and during pollen season<br>* Other names: Sublingual immunotherapy tablet;|
| Placebo Comparator: Placebo<br>Placebo tablet | Drug: Placebo tablet<br>* One sublingual tablet daily during 4 months before pollen season and during pollen season<br>* Other names: Sublingual placebo tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Rhinoconjunctivitis Total Symptom Score | Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment. Participants assessed daily, during the pollen period, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). The lower the score, the better the outcome. | Pollen period (average of 32 days in the ITT set) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sublingual immunotherapy, Grass pollen tablet, Allergic rhinoconjunctivitis