Efficacy and Safety of 100IR, 300IR, 500IR Sublingual House Dust Mite (HDM) Tablets in Allergic Rhinitis Environment Exposure Chamber Model

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01527188
Recruitment Status : Completed
First Posted : February 6, 2012
Last Update Posted : August 2, 2013
Information provided by (Responsible Party):
Stallergenes Greer

Brief Summary:
The purpose of this study is to assess the effect of 3 doses of sublingual house dust mite (HDM) tablets versus placebo in the change from baseline of rhinitis total symptom score during the allergen chamber challenge before and after 6 months of treatment.

Condition or disease Intervention/treatment Phase
House Dust Mites Allergic Rhinitis Biological: 100IR Biological: 300IR Biological: 500IR Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 355 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase II Study to Assess the Efficacy and Safety of 100IR, 300IR and 500IR Sublingual Tablets of House Dust Mite Allergen for the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber Model
Study Start Date : January 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: 100IR Biological: 100IR
100IR sublingual tablet of

Experimental: 300IR Biological: 300IR
300IR sublingual tablets of

Experimental: 500IR Biological: 500IR
500IR sublingual tablet of

Placebo Comparator: Placebo Other: Placebo
Placebo sublingual tablet of

Primary Outcome Measures :
  1. Rhinitis total symptom score (RTSS) [ Time Frame: 6 months ]
    Rhinitis total symptom score = sneezing+rhinorrhea+nasal pruritus+ nasal congestion scored on 0-3 scale, total score range 0-12

Secondary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 6 months and 18 months ]
    Analysis of adverse events

  2. Rhinitis total symptom score [ Time Frame: 18 months ]
    Rhinitis total symptom score=sneezing+rhinorrhea+nasal pruritus+nasal congestion scored on 0-3 scale, total score range 0-12

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • history of HDM rhinitis allergy for > 1 year
  • sensitized to D. pteronyssinus and/or D. farinae
  • RTSS >= 6 at least 2 time points during allergen challenge session

Exclusion Criteria:

  • co sensitization to other allergen than HDM
  • FEV1 < 80%
  • Asthma GINA > 1

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 identifier (NCT number): NCT01527188

Canada, Ontario
Cetero Research
Mississauga, Ontario, Canada, L4W 1N2
Sponsors and Collaborators
Stallergenes Greer

Responsible Party: Stallergenes Greer Identifier: NCT01527188     History of Changes
Other Study ID Numbers: VO67.10
First Posted: February 6, 2012    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: August 2013

Keywords provided by Stallergenes Greer:
allergic rhinitis

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