Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts
NCT ID: NCT01608243
Last Updated: 2014-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
94 participants
INTERVENTIONAL
2012-05-31
2014-06-30
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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SLIT tablets of HDM allergen extracts
SLIT tablets of house dust mite allergen extracts
10 dosing days
Placebo
Matching placebo
10 dosing days
Interventions
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SLIT tablets of house dust mite allergen extracts
10 dosing days
Matching placebo
10 dosing days
Eligibility Criteria
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Inclusion Criteria
* Male or female patient from 18 to 50 years.
* Diagnosed asthma with medical history consistent with HDM-induced allergic asthma.
* Positive SPT to House Dust Mites(HDM)and HDM-specific IgE serum value ≥ 0.7 kU/L.
* Stable asthma treatments.
* Spirometry with best FEV1 \> 70% of the predicted value.
* Spirometry with reversibility of FEV1 of ≥ 12% and ≥ 200 mL.
* Asthma Control Test™ (ACT) score ≥ 20.
Exclusion Criteria
* Co-sensitisation to any allergen possibly leading to clinically relevant respiratory allergy likely to significantly change the symptoms of the patient throughout the treatment period.
* 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.
* Patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.
* Female patient pregnant or breast-feeding/lactating.
* Female patient of childbearing potential not using a medically accepted contraceptive method.
* Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
* Patient who received allergen immunotherapy for HDM in the last 10 years.
* Ongoing treatment by immunotherapy with another allergen.
18 Years
50 Years
ALL
No
Sponsors
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Stallergenes Greer
INDUSTRY
Responsible Party
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Principal Investigators
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Pascal Demoly, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Arnaud de Villeneuve, Montpellier, France
Locations
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CHU Arnaud de Villeneuve
Montpellier, , France
Countries
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Other Identifiers
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VO71.11
Identifier Type: -
Identifier Source: org_study_id
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