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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

381 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-01-31

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.

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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.

Conditions

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Primary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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300 IR

300 IR grass pollen allergen extract tablet

Group Type EXPERIMENTAL

300 IR

Intervention Type DRUG

300 IR grass pollen allergen extract tablet starting 2 months before the grass pollen season and during the grass pollen season

Placebo

Placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo sublingual tablet starting 2 months before the grass pollen season and during the grass pollen season

Interventions

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300 IR

300 IR grass pollen allergen extract tablet starting 2 months before the grass pollen season and during the grass pollen season

Intervention Type DRUG

Placebo

Placebo sublingual tablet starting 2 months before the grass pollen season and during the grass pollen season

Intervention Type DRUG

Other Intervention Names

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Sublingual immunotherapy tablet Sublingual placebo tablet

Eligibility Criteria

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Inclusion Criteria

1. Male or female outpatients aged 12 to 65 years (inclusive).
2. Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two grass pollen seasons.
3. Positive SPT
4. RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18.

Exclusion Criteria

1. Positive SPT to any other seasonal allergens present during the grass pollen season
2. Patients with clinically significant confounding symptoms of allergy to other allergens
3. Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed.
4. Patients with moderate or severe persistent asthma (Global Initiative for Asthma \[GINA\] 3 or 4).

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No