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

February 1, 2012
August 1, 2013
January 2011
March 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01527188 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of 100IR, 300IR, 500IR Sublingual House Dust Mite (HDM) Tablets in Allergic Rhinitis Environment Exposure Chamber Model
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
House Dust Mites Allergic Rhinitis
  • Biological: 100IR
    100IR sublingual tablet of
  • Biological: 300IR
    300IR sublingual tablets of
  • Biological: 500IR
    500IR sublingual tablet of
  • Other: Placebo
    Placebo sublingual tablet of
  • Experimental: 100IR
    Intervention: Biological: 100IR
  • Experimental: 300IR
    Intervention: Biological: 300IR
  • Experimental: 500IR
    Intervention: Biological: 500IR
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
355
September 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01527188
VO67.10
No
Stallergenes
Stallergenes
Not Provided
Not Provided
Stallergenes
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP