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

Phase 3

Completed

• Conditions: Primary Disease
• Interventions: Drug: 300 IR; Drug: Placebo

• Registration Number: NCT00803244
• Lead Sponsor: Stallergenes Greer

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.

Study Timeline

• Study First Submitted: 2008-11-27
• Study First Submitted QC: 2008-12-04
• Study First Posted: 2008-12-05
• Study Start: 2009-01
• Primary Completion: 2009-08
• Study Completion: 2010-01
• Results First Submitted: 2016-01-25
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-18
• Last Update Submitted: 2016-04-18
• Results First Posted: 2016-05-25
• Last Update Posted: 2016-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 381

Inclusion Criteria

Not provided

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
300 IR	300 IR	300 IR grass pollen allergen extract tablet
Placebo	Placebo	Placebo tablet

Primary Outcome Measures

Name	Time	Method
Average Adjusted Symptom Score (AAdSS)	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.

Trial Locations

Locations (6)

Hop Montauban; 🇫🇷 Montauban, France

Cab medical; 🇫🇷 Orange, France

Stallergenes Sa; 🇫🇷 Antony, France

HGU La Paz; 🇪🇸 Madrid, Spain

Azienda Ospedaliera; 🇮🇹 Parma, Italy

Complejo Hospitalario de Caceres; 🇪🇸 Caceres, Spain