Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and Children

A Randomised,Double-blind,Placebo-controlled,Multi National,Phase III Trial to Assess the Efficacy and Safety of 300 IR Sublingual Immunotherapy Administered as Allergen-based Tablets Once Daily to Adolescents and Children Above the Age of 5 Years, Suffering From House Dust Mite Allergic Rhinitis

The purpose of this study is to assess the efficacy of one dose of sublingual immunotherapy (SLIT) administered to children and adolescents as allergen-based tablets once daily over a period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication use.

Study Overview

• Status: Terminated
• Conditions: Allergic Rhinitis Due to Dust Mite
• Intervention / Treatment: Drug: Dpte and Dfar Allergen Extracts; Drug: placebo

Detailed Description

After the screening period, the patients will be administered 300 IR house dust mite allergen based tablets or placebo, once a day, for a period of 36 months with two windows of 8 months and 6 months without treatment. The carry over effect will be evaluated after a treatment free follow up period of 24 months.

An independent Data Monitoring Committee will be constituted to evaluate the efficacy and safety data at the end of Year 1 and Year 3, and the post-treatment long-term efficacy data at the end of year 4.

• Study Type: Interventional
• Enrollment (Actual): 471
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female outpatients, aged 5-17 years inclusive
• History of house dust mite-related allergic rhinitis for at least 1 year requiring regular intake of symptomatic treatment(s)
• Sensitised to D. pteronyssinus and/or D. farinae (positive skin prick test with wheal diameter greater than 3 mm and specific IgE level ≥ 0.7 kU/L)

Exclusion Criteria:

• Co-sensitization associated with clinically relevant allergic rhinitis, sinusitis, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study (that means patient symptomatic to another allergen than house dust mites to which the patient will be exposed during the study, i.e. will notably be excluded

• patients sensitised to cat or dog allergens and regularly exposed to these allergens
• patients sensitised to aspergillus, cladosporium, alternaria
• patients sensitised to parietaria , ragweed, or mugwort, if this allergen is endemic to the region

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dpte and Dfar Allergen Extract	Drug: Dpte and Dfar Allergen Extracts; 300 IR, once a day, for one year.; Other Names: Dermatofagoides Pteronyssinus; Dermatofagoides Farinae
Placebo Comparator: Placebo tablets	Drug: placebo; once a day, for one year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Assessment	Evaluation of the Average Adjusted Symptom Score (AASS) during the treatment period	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Assessment at the end of the treatment phase and at the end of the Treatment free follow up phase	AASS, ARTSS (average rhinitis total symptom score), ARMS (average rescue medication score),ARSS (individual average rhinoconjunctivitis symptom score), RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire Score), Safety	60 months

Collaborators and Investigators

• Sponsor: Stallergenes Greer
• Investigators: Study Chair: Ulrich Wahn, MD, Charite- Campus Virchow klinikum

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: September 9, 2010
• First Submitted That Met QC Criteria: September 9, 2010
• First Posted (Estimate): September 10, 2010

Study Record Updates

• Last Update Posted (Estimate): December 21, 2011
• Last Update Submitted That Met QC Criteria: December 20, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: VO64.08; 2009-011999-30 (EudraCT Number)