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

Primary Purpose

Allergic Rhinitis Due to Dust Mite

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Dpte and Dfar Allergen Extracts
placebo
Sponsored by
Stallergenes Greer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis Due to Dust Mite

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Dpte and Dfar Allergen Extract

    Placebo tablets

    Arm Description

    Outcomes

    Primary Outcome Measures

    Efficacy Assessment
    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
    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

    Full Information

    First Posted
    September 9, 2010
    Last Updated
    December 20, 2011
    Sponsor
    Stallergenes Greer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01199133
    Brief Title
    Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and Children
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2011
    Overall Recruitment Status
    Terminated
    Why Stopped
    Following the DSMB recommendation. Study population being insufficiently symptomatic to enable differentiation between treatment and placebo. No safety concerns
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    January 2011 (Actual)
    Study Completion Date
    September 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Stallergenes Greer

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Rhinitis Due to Dust Mite

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    471 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dpte and Dfar Allergen Extract
    Arm Type
    Active Comparator
    Arm Title
    Placebo tablets
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Dpte and Dfar Allergen Extracts
    Other Intervention Name(s)
    Dermatofagoides Pteronyssinus, Dermatofagoides Farinae
    Intervention Description
    300 IR, once a day, for one year.
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    once a day, for one year.
    Primary Outcome Measure Information:
    Title
    Efficacy Assessment
    Description
    Evaluation of the Average Adjusted Symptom Score (AASS) during the treatment period
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Efficacy Assessment at the end of the treatment phase and at the end of the Treatment free follow up phase
    Description
    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
    Time Frame
    60 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ulrich Wahn, MD
    Organizational Affiliation
    Charite- Campus Virchow klinikum
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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