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

This study has been terminated.
(Following the DSMB recommendation. Study population being insufficiently symptomatic to enable differentiation between treatment and placebo. No safety concerns)
Sponsor:
Information provided by (Responsible Party):
Stallergenes
ClinicalTrials.gov Identifier:
NCT01199133
First received: September 9, 2010
Last updated: December 20, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis Due to Dust Mite
 Drug: Dpte and Dfar Allergen Extracts
Drug: placebo
 Phase 3

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

Further study details as provided by Stallergenes:

Primary Outcome Measures:
  • Efficacy Assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluation of the Average Adjusted Symptom Score (AASS) during the treatment period


Secondary Outcome Measures:
  • Efficacy Assessment at the end of the treatment phase and at the end of the Treatment free follow up phase [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
    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


Enrollment: 471
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: 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.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199133

Sponsors and Collaborators
Stallergenes
Investigators
Study Chair: Ulrich Wahn, MD Charite- Campus Virchow klinikum
  More Information

No publications provided

Responsible Party: Stallergenes
ClinicalTrials.gov Identifier: NCT01199133     History of Changes
Other Study ID Numbers: VO64.08, 2009-011999-30
Study First Received: September 9, 2010
Last Updated: December 20, 2011
Health Authority: Germany: Paul-Ehrlich-Institut
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ireland: Irish Medicines Board
Denmark: Danish Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Hungary: National Institute of Pharmacy
Slovakia: State Institute for Drug Control
Ukraine: State Pharmacological Center - Ministry of Health
Romania: National Medicines Agency

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 17, 2013