Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.

Detailed Description
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To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on: - The Average Adjusted Symptom Score (AASS). To document the safety of the treatment.

Official Title
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A Randomised, Double-blind, Placebo-controlled, Multi National, Phase III Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablet, Starting 2 Months Before the Grass Pollen Season Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis

Conditions
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Primary Disease

Intervention / Treatment
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* Drug: 300 IR
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male or female outpatients aged 12 to 65 years (inclusive). Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two grass pollen seasons. Positive SPT RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18. Exclusion Criteria: Positive SPT to any other seasonal allergens present during the grass pollen season Patients with clinically significant confounding symptoms of allergy to other allergens Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed. Patients with moderate or severe persistent asthma (Global Initiative for Asthma [GINA] 3 or 4).

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 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: 300 IR<br>300 IR grass pollen allergen extract tablet | Drug: 300 IR<br>* 300 IR grass pollen allergen extract tablet starting 2 months before the grass pollen season and during the grass pollen season<br>* Other names: Sublingual immunotherapy tablet;|
| Placebo Comparator: Placebo<br>Placebo tablet | Drug: Placebo<br>* Placebo sublingual tablet starting 2 months before the grass pollen season and during the grass 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 Adjusted Symptom Score (AAdSS) | The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use. Participants assessed daily, during the pollen period while on treatment, 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). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome. | Pollen period (average of 32.1 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allergic rhinoconjunctivitis