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

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ClinicalTrials.gov Identifier: NCT01199133
Recruitment Status : Terminated (Following the DSMB recommendation. Study population being insufficiently symptomatic to enable differentiation between treatment and placebo. No safety concerns)
First Posted : September 10, 2010
Last Update Posted : December 21, 2011
Sponsor:
Information provided by (Responsible Party):
Stallergenes Greer

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.

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

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  (Clinical Trial)
Actual Enrollment : 471 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : September 2011

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.




Primary Outcome Measures :
  1. Efficacy Assessment [ Time Frame: 12 months ]
    Evaluation of the Average Adjusted Symptom Score (AASS) during the treatment period


Secondary Outcome Measures :
  1. Efficacy Assessment at the end of the treatment phase and at the end of the Treatment free follow up phase [ Time Frame: 60 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199133


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

Responsible Party: Stallergenes Greer
ClinicalTrials.gov Identifier: NCT01199133     History of Changes
Other Study ID Numbers: VO64.08
2009-011999-30 ( EudraCT Number )
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: December 21, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases