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

Sponsors

Lead Sponsor: Stallergenes Greer

Source 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.

Overall Status Completed
Start Date January 2009
Completion Date January 2010
Primary Completion Date August 2009
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Average Adjusted Symptom Score (AAdSS) Pollen period (average of 32.1 days)
Enrollment 381
Condition
Intervention

Intervention Type: Drug

Intervention Name: 300 IR

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

Arm Group Label: 300 IR

Other Name: Sublingual immunotherapy tablet

Intervention Type: Drug

Intervention Name: Placebo

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

Arm Group Label: Placebo

Other Name: Sublingual placebo tablet

Eligibility

Criteria:

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).

Gender: All

Minimum Age: 12 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
DE BLAY Frédéric, MD Principal Investigator NHC, Hôpitaux Universitaires de Strasbourg
Location
Facility:
Stallergenes Sa | Antony, 92183, France
Hop Montauban | Montauban, France
Cab medical | Orange, France
Azienda Ospedaliera | Parma, Italy
Complejo Hospitalario de Caceres | Caceres, Spain
HGU La Paz | Madrid, Spain
Location Countries

France

Italy

Spain

Verification Date

April 2016

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 300 IR

Type: Experimental

Description: 300 IR grass pollen allergen extract tablet

Label: Placebo

Type: Placebo Comparator

Description: Placebo tablet

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov