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

NCT ID: NCT01527188

Last Updated: 2025-02-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-08

Study Completion Date

2012-09-19

Brief Summary

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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.

Detailed Description

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Conditions

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Allergic Rhinitis Due to House Dust Mite

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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100 IR

100 IR house dust mites allergen extract tablet

Group Type EXPERIMENTAL

100 IR house dust mites allergen extract tablet

Intervention Type DRUG

One sublingual tablet daily during 6 months

300 IR

300 IR house dust mites allergen extract tablet

Group Type EXPERIMENTAL

300 IR house dust mites allergen extract tablet

Intervention Type DRUG

One sublingual tablet daily during 6 months

500 IR

500 IR house dust mites allergen extract tablet

Group Type EXPERIMENTAL

500 IR house dust mites allergen extract tablet

Intervention Type DRUG

One sublingual tablet daily during 6 months

Placebo

Placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo tablet

Intervention Type DRUG

One sublingual tablet daily during 6 months

Interventions

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100 IR house dust mites allergen extract tablet

One sublingual tablet daily during 6 months

Intervention Type DRUG

300 IR house dust mites allergen extract tablet

One sublingual tablet daily during 6 months

Intervention Type DRUG

500 IR house dust mites allergen extract tablet

One sublingual tablet daily during 6 months

Intervention Type DRUG

Placebo tablet

One sublingual tablet daily during 6 months

Intervention Type DRUG

Other Intervention Names

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Sublingual immunotherapy tablet Sublingual immunotherapy tablet Sublingual immunotherapy tablet Sublingual placebo tablet

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stallergenes Greer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Couroux, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Cetero Research / PRACS Institute

Locations

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Cetero Research

Mississauga, Ontario, Canada

Site Status

Countries

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Canada

References

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Worm M, Demoly P, Okamoto Y, Vidal C, Daghildjian K, Yan K, Casale TB, Bergmann KC. Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data. World Allergy Organ J. 2024 Jun 25;17(7):100924. doi: 10.1016/j.waojou.2024.100924. eCollection 2024 Jul.

Reference Type DERIVED
PMID: 39035788 (View on PubMed)

Other Identifiers

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VO67.10

Identifier Type: -

Identifier Source: org_study_id

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