Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma
NCT ID: NCT01930461
Last Updated: 2015-12-18
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
PHASE2
386 participants
INTERVENTIONAL
2013-09-30
2015-08-31
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 (A)
SLIT tablets of HDM allergen extracts, 3 different doses (A)
SLIT tablets of HDM allergen extracts, 3 different doses (A)
Two sublingual tablets daily for 13 months
SLIT (B)
SLIT tablets of HDM allergen extracts, 3 different doses (B)
SLIT tablets of HDM allergen extracts, 3 different doses (B)
Two sublingual tablets daily for 13 months
SLIT (C)
SLIT tablets of HDM allergen extracts, 3 different doses (C)
SLIT tablets of HDM allergen extracts, 3 different doses (C)
Two sublingual tablets daily for 13 months
Placebo
Placebo matching the SLIT tablets of HDM allergen extracts
Placebo matching the SLIT tablets of HDM allergen extracts
Two sublingual tablets daily for 13 months
Interventions
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SLIT tablets of HDM allergen extracts, 3 different doses (A)
Two sublingual tablets daily for 13 months
SLIT tablets of HDM allergen extracts, 3 different doses (B)
Two sublingual tablets daily for 13 months
SLIT tablets of HDM allergen extracts, 3 different doses (C)
Two sublingual tablets daily for 13 months
Placebo matching the SLIT tablets of HDM allergen extracts
Two sublingual tablets daily for 13 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female from 18 to 50 years of age.
* Diagnosed asthma and rhinitis with medical history consistent with HDM-induced allergic asthma and rhinitis.
* Positive SPT to HDM and and HDM-specific IgE serum value ≥ 0.7 kU/L.
* Stable asthma therapies.
* Spirometry (pre-bronchodilator) with best FEV1 ≥ 70% of the predicted value.
* Spirometry with reversibility in FEV1 of ≥ 12% and ≥ 200 mL.
* Asthma Control Test™ (ACT) score ≤ 19.
Exclusion Criteria
* Patient with a urine level of cotinine ≥ 500 ng/mL.
* Co-sensitisation to any allergen possibly leading to clinically relevant symptoms likely to significantly change the asthma symptoms of the subject during the study.
* Patient who received allergen immunotherapy for HDM within the past 10 years.
* Ongoing immunotherapy for an aeroallergen other than house dust mite.
* Patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.
* Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
* Pregnant women or breast-feeding/lactating.
* Women with childbearing potential who are not using a medically accepted birth control method.
* 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.
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
Montpellier, France
Locations
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CHU Arnaud de Villeneuve
Montpellier, , France
NHC, Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
Universitätsmedizin Berlin - Allergie-Centrum-Charité
Berlin, , Germany
SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi
Lodz, , Poland
Majorek-Olechowska Bernadetta
Tarnów, , Poland
Countries
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Other Identifiers
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VO72.12
Identifier Type: -
Identifier Source: org_study_id