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

Allergic Rhinitis Due to Dust Mite Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01199133
• Other study ID #: VO64.08
• Secondary ID: 2009-011999-30
• Status: Terminated
• Phase: Phase 3
• First received: September 9, 2010
• Last updated: December 20, 2011
• Start date: October 2009
• Est. completion date: September 2011

Study information

• Verified date: December 2011
• Source: Stallergenes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstitutFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Ireland: Irish Medicines BoardDenmark: Danish Medicines AgencySpain: Agencia Española de Medicamentos y Productos SanitariosHungary: National Institute of PharmacySlovakia: State Institute for Drug ControlUkraine: State Pharmacological Center - Ministry of HealthRomania: National Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 471
• Est. completion date: September 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Allergic Rhinitis Due to Dust Mite
• Rhinitis

Intervention

Drug:
• Dpte and Dfar Allergen Extracts
300 IR, once a day, for one year.
• placebo
once a day, for one year.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stallergenes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy Assessment	Evaluation of the Average Adjusted Symptom Score (AASS) during the treatment period	12 months	No
Secondary	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	Yes