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

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ClinicalTrials.gov Identifier: NCT01527188
Recruitment Status : Completed
First Posted : February 6, 2012
Last Update Posted : August 2, 2013
Sponsor:
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
Primary Completion Date : March 2012
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



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

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 ClinicalTrials.gov identifier (NCT number): NCT01527188


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

Responsible Party: Stallergenes Greer
ClinicalTrials.gov 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:
HDM
allergic rhinitis

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