Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract

Study Overview
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Brief Summary
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The objective of this study is to assess the effect of grass pollen extract SLIT tablets on the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms in response to grass pollen challenge after one week, one, two and four months of treatment in patients suffering from Seasonal Allergic Rhinoconjunctivitis (SAR) due to grass pollen.

Detailed Description
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The purpose of this study is to determine whether SLIT tablets are effective on symptoms of allergic rhinitis compared to placebo in patients suffering from allergic rhinitis to grass pollen when exposed in an allergen chamber and also to determine the onset of action of SLIT tablets on allergic rhinitis symptoms.

Official Title
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A Randomised, Double-blind, in Parallel Groups Placebo-controlled, Mono-centre, Phase I Study to Assess After Allergen Challenge in an Allergen Exposition Chamber the Effect and Its Time Course of Sublingual Immunotherapy (SLIT) Administered as 300IR Allergen-based Tablets Once Daily to Adults Suffering From Grass Pollen Rhinoconjunctivitis

Conditions
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Seasonal Allergic Rhinitis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatients 18-50 years old grass pollen rhinoconjunctivitis of at least 2 years. positive specific skin prick test and a specific IgE dosage level of at least 0.70 kU/L at screening. written consent a positive response to the baseline challenge test (RTSS reaches 7 at one time-point at least during baseline challenge) Exclusion Criteria: Allergic rhino-conjunctivitis due to a co-sensitisation, likely to significantly change the symptoms of the subject throughout the study Asthma requiring treatment other than short-acting beta-2 inhaled agonists. Desensitisation treatment for grass pollen in the previous five years and current immunotherapy with another allergen.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 300 IR<br>300 IR grass pollen allergen extract tablet | Drug: 300 IR grass pollen allergen extract tablet<br>* 300 IR grass pollen allergen extract tablet once daily during four months<br>* Other names: Sublingual immunotherapy tablet;|
| Placebo Comparator: Placebo<br>Placebo tablet | Drug: Placebo tablet<br>* Placebo tablet once daily during four months<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 of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours | The primary efficacy variable was the Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) during the four-hour (]0-4] hours) grass pollen allergen challenge at end point (after four months of treatment) of the 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes). The severity of each symptom was evaluated by the subject, before allergen exposure and every 15 minutes during allergen challenge on a scale of 0 to 3; 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms, total score range was 0 to 18. The ARTSS ]0-4] hours was calculated as the mean of the RTSSs at each timepoint during the allergen challenge (i.e., 16 timepoints from 15 minutes to 4 hours) after 4 months of treatment (endpoint). The lower the score, the better the outcome. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sublingual immunotherapy, Rhinitis, Conjunctivitis, Allergen challenge, Allergen exposition chamber, Grass pollen tablet, Allergic rhinoconjunctivitis