Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis (With or Without Asthma)

Primary Disease Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled, Multi National, Phase III Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT), Starting 2 Months Before the Grass Pollen Season, Administered as Allergen Based Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis (With or Without Asthma)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803244
• Other study ID #: VO60.08
• Status: Completed
• Phase: Phase 3
• First received: November 27, 2008
• Last updated: September 23, 2011
• Start date: January 2009
• Est. completion date: January 2010

Study information

• Verified date: September 2011
• Source: Stallergenes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Czech Republic: State Institute for Drug ControlItaly: Ethics CommitteeSpain: Spanish Agency of MedicinesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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).

• The Average Rhinoconjunctivitis Total Symptom Score (ARTSS) of the six rhinoconjunctivitis symptoms sneezing, rhinorrhoea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes.

• The Average Rescue Medication Score (ARMS) and use of rescue medication (antihistamine [oral form or / and eye drops], nasal corticosteroid and oral corticosteroid).

• The Average Combined Score (ACS). A score taking into account the RTSS and Rescue Medication Score (RMS).

• Each of the six individual Average Rhinoconjunctivitis Symptom Scores (ARSS).

• The proportion of symptom-controlled days (PSCD).

• The global evaluation of the efficacy of sublingual tablets of grass pollen allergen extract by the patient.

To document the safety of the treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: January 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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. An RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18.

5. Patients in general good health

6. Patients with FEV1 = 80% of the predicted value.

7. Female patients are eligible if they do not have child bearing potential.

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).

5. Patients with seasonal mild persistent asthma (GINA 2) necessitating treatment with inhaled glucocorticosteroids at a dose level greater than 400 mcg budesonide dose-equivalents.

6. Patients who have received any desensitisation treatment for grass pollen in the last 5 years.

7. Patients with ongoing treatment by immunotherapy with any other allergen.

8. Patients with any nasal or oral condition

9. Patients with a known history of hypersensitivity or intolerance to any of the excipients in the investigational product (such as galactose intolerance).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Primary Disease

Intervention

Biological:
• 300 IR grass pollen tablet
one tablet per day during 5 months
• Placebo tablet
one tablet per day during 5 months

Locations

Country	Name	City	State
France	Stallergenes Sa	Antony
France	Hop Montauban	Montauban
France	Cab medical	Orange
Italy	Azienda Ospedaliera	Parma
Spain	Complejo Hospitalario de Caceres	Caceres
Spain	HGU La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Stallergenes

Countries where clinical trial is conducted

France,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AASS (Average Adjusted Symptom Score): score taking into account Rhinoconjunctivitis Symptoms and rescue medication use.		1 year	No
Secondary	Efficacy on: - ARTSS of the 6 rhinoconjunctivitis symptoms, - ARMS and use of rescue medication, - ACS, - Each of the 6 individual ARSS, - Proportion of symptom-controlled days. - Global patient evaluation of the efficacy of treatment, - Safety		1 year	Yes