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

Primary Purpose

House Dust Mites Allergic Rhinitis

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
100IR
300IR
500IR
Placebo
Sponsored by
Stallergenes Greer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for House Dust Mites Allergic Rhinitis focused on measuring HDM, allergic rhinitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cetero Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

100IR

300IR

500IR

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Rhinitis total symptom score (RTSS)
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
Analysis of adverse events
Rhinitis total symptom score
Rhinitis total symptom score=sneezing+rhinorrhea+nasal pruritus+nasal congestion scored on 0-3 scale, total score range 0-12

Full Information

First Posted
February 1, 2012
Last Updated
August 1, 2013
Sponsor
Stallergenes Greer
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1. Study Identification

Unique Protocol Identification Number
NCT01527188
Brief Title
Efficacy and Safety of 100IR, 300IR, 500IR Sublingual House Dust Mite (HDM) Tablets in Allergic Rhinitis Environment Exposure Chamber Model
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 Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stallergenes Greer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
House Dust Mites Allergic Rhinitis
Keywords
HDM, allergic rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
355 (Actual)

8. Arms, Groups, and Interventions

Arm Title
100IR
Arm Type
Experimental
Arm Title
300IR
Arm Type
Experimental
Arm Title
500IR
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
100IR
Intervention Description
100IR sublingual tablet of
Intervention Type
Biological
Intervention Name(s)
300IR
Intervention Description
300IR sublingual tablets of
Intervention Type
Biological
Intervention Name(s)
500IR
Intervention Description
500IR sublingual tablet of
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo sublingual tablet of
Primary Outcome Measure Information:
Title
Rhinitis total symptom score (RTSS)
Description
Rhinitis total symptom score = sneezing+rhinorrhea+nasal pruritus+ nasal congestion scored on 0-3 scale, total score range 0-12
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety and tolerability
Description
Analysis of adverse events
Time Frame
6 months and 18 months
Title
Rhinitis total symptom score
Description
Rhinitis total symptom score=sneezing+rhinorrhea+nasal pruritus+nasal congestion scored on 0-3 scale, total score range 0-12
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Cetero Research
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1N2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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