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
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View full resultsBasic Information
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COMPLETED
PHASE2
355 participants
INTERVENTIONAL
2010-12-08
2012-09-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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100 IR
100 IR house dust mites allergen extract tablet
100 IR house dust mites allergen extract tablet
One sublingual tablet daily during 6 months
300 IR
300 IR house dust mites allergen extract tablet
300 IR house dust mites allergen extract tablet
One sublingual tablet daily during 6 months
500 IR
500 IR house dust mites allergen extract tablet
500 IR house dust mites allergen extract tablet
One sublingual tablet daily during 6 months
Placebo
Placebo tablet
Placebo tablet
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
300 IR house dust mites allergen extract tablet
One sublingual tablet daily during 6 months
500 IR house dust mites allergen extract tablet
One sublingual tablet daily during 6 months
Placebo tablet
One sublingual tablet daily during 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* sensitized to D. pteronyssinus and/or D. farinae
* RTSS \>= 6 at least 2 time points during allergen challenge session
Exclusion Criteria
* FEV1 \< 80%
* Asthma GINA \> 1
18 Years
55 Years
ALL
No
Sponsors
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Stallergenes Greer
INDUSTRY
Responsible Party
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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
Countries
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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.
Other Identifiers
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VO67.10
Identifier Type: -
Identifier Source: org_study_id
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