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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Disease
• Intervention / Treatment: Drug: 300 IR; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 381
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Antony, France, 92183
    • Stallergenes Sa
  • Montauban, France
    • Hop Montauban
  • Orange, France
    • Cab medical
• Italy
  • Parma, Italy
    • Azienda Ospedaliera
• Spain
  • Caceres, Spain
    • Complejo Hospitalario de Caceres
  • Madrid, Spain
    • HGU La Paz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo tablet	Drug: Placebo; Placebo sublingual tablet starting 2 months before the grass pollen season and during the grass pollen season; Other Names: Sublingual placebo tablet
Experimental: 300 IR; 300 IR grass pollen allergen extract tablet	Drug: 300 IR; 300 IR grass pollen allergen extract tablet starting 2 months before the grass pollen season and during the grass pollen season; Other Names: Sublingual immunotherapy tablet

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Stallergenes Greer
• Investigators: Principal Investigator: DE BLAY Frédéric, MD, NHC, Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: November 27, 2008
• First Submitted That Met QC Criteria: December 4, 2008
• First Posted (Estimate): December 5, 2008

Study Record Updates

• Last Update Posted (Estimate): May 25, 2016
• Last Update Submitted That Met QC Criteria: April 18, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: allergic rhinoconjunctivitis
• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Conjunctivitis
• Other Study ID Numbers: VO60.08