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
Overview
- Phase
- Phase 3
- Intervention
- 300 IR
- Conditions
- Primary Disease
- Sponsor
- Stallergenes Greer
- Enrollment
- 381
- Locations
- 6
- Primary Endpoint
- Average Adjusted Symptom Score (AAdSS)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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).
Arms & Interventions
300 IR
300 IR grass pollen allergen extract tablet
Intervention: 300 IR
Placebo
Placebo tablet
Intervention: Placebo
Outcomes
Primary Outcomes
Average Adjusted Symptom Score (AAdSS)
Time Frame: Pollen period (average of 32.1 days)
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.