Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents
NCT ID: NCT01919554
Last Updated: 2025-01-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
37 participants
INTERVENTIONAL
2013-07-31
2013-09-30
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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500 IR
500 IR house dust mites allergen extract tablet
500 IR house dust mites allergen extract tablet
One sublingual tablet daily during 10 days
1000 IR
1000 IR house dust mites allergen extract tablet
1000 IR house dust mites allergen extract tablet
Two sublingual tablets daily during 10 days
1500 IR
1500 IR house dust mites allergen extract tablet
1500 IR house dust mites allergen extract tablet
Three sublingual tablets daily during 10 days
Placebo
Placebo tablet
Placebo tablet
One, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets
Interventions
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500 IR house dust mites allergen extract tablet
One sublingual tablet daily during 10 days
1000 IR house dust mites allergen extract tablet
Two sublingual tablets daily during 10 days
1500 IR house dust mites allergen extract tablet
Three sublingual tablets daily during 10 days
Placebo tablet
One, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female patient from 12 to 17 years.
* Diagnosed rhinitis with medical history consistent with HDM-induced allergic rhinitis for at least 1 year before visit 1
* Positive Skin Prick Test to House Dust Mites(HDM)and HDM-specific IgE serum value ≥ 0.7 kUnit/L.
* Concommittant controlled asthma allowed up to GINA 1 or 2 treatment step
* Spirometry with best FEV1 \> 80% of predicted FEV1.
Exclusion Criteria
* Patient has undergone recent nasal surgery
* Patient with asthma receiving therapy consistent with GINA (Global INitiative for Asthama) treatment step 3, 4, or 5.
* Patient with partially controlled or uncontrolled asthma
* Patient with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or the outcome of this study.
* Female patient pregnant or breast-feeding/lactating.
* Female patient of childbearing potential planning a pregnancy during this trial or not using a medically accepted contraceptive method.
* Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
* Patient who received allergy specific immunotherapy for house dust mites for more than 1 month in the 5 years before screening or who is currently receiving immunotherapy with any allergen.
* patient with a history of anaphylaxis
* patient having participated in any clinical study within the 12 weeks before visit 1
12 Years
17 Years
ALL
No
Sponsors
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Syneos Health
OTHER
Stallergenes Greer
INDUSTRY
Responsible Party
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Principal Investigators
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Piyush Patel, MD
Role: PRINCIPAL_INVESTIGATOR
Inflamax Research Incorporated
Locations
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Inflamax Research Inc.
Mississauga, Ontario, Canada
Countries
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Other Identifiers
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VO73.13
Identifier Type: -
Identifier Source: org_study_id
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