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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stallergenes
ClinicalTrials.gov Identifier:
NCT01527188
First received: February 1, 2012
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
House Dust Mites Allergic Rhinitis
Biological: 100IR
Biological: 300IR
Biological: 500IR
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Stallergenes:

Primary Outcome Measures:
  • Rhinitis total symptom score (RTSS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Rhinitis total symptom score = sneezing+rhinorrhea+nasal pruritus+ nasal congestion scored on 0-3 scale, total score range 0-12


Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: 6 months and 18 months ] [ Designated as safety issue: No ]
    Analysis of adverse events

  • Rhinitis total symptom score [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Rhinitis total symptom score=sneezing+rhinorrhea+nasal pruritus+nasal congestion scored on 0-3 scale, total score range 0-12


Enrollment: 355
Study Start Date: January 2011
Study Completion Date: September 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527188

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

No publications provided

Responsible Party: Stallergenes
ClinicalTrials.gov Identifier: NCT01527188     History of Changes
Other Study ID Numbers: VO67.10
Study First Received: February 1, 2012
Last Updated: August 1, 2013
Health Authority: Canada: Health Canada

Keywords provided by Stallergenes:
HDM
allergic rhinitis

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

ClinicalTrials.gov processed this record on July 26, 2014