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RESEARCH PRODUCT
A 300 IR sublingual tablet is an effective, safe treatment for house dust mite-induced allergic rhinitis: An international, double-blind, placebo-controlled, randomized phase III clinical trial.
Krzysztof KowalPeter S. CreticosMargitta WormPhilippe GevaertPascal DemolyPascal DemolyFrédéric De BlayN. NenashevaOliver PfaarMiguel Tortajada-girbésCarmen VidalJonathan CorrenThomas B. CasaleGiovanni PassalacquaPeter HellingsMartine Le Gallsubject
0301 basic medicineAllergen immunotherapy; allergic rhinitis; allergy; house-dust mite; medication score; sublingual immunotherapy; symptom score; tablet; total combined scoreMaleAllergyInternational Cooperation*total combined scoreSeverity of Illness Indexlaw.invention0302 clinical medicineRandomized controlled triallaw*allergyClinical endpointImmunology and Allergy[SDV.IMM.ALL]Life Sciences [q-bio]/Immunology/Allergologyhouse dust miteAllergen immunotherapybiologyPyroglyphidae*tablet*allergic rhinitis*sublingual immunotherapy3. Good healthhouse-dust mitetotal combined score*Allergen immunotherapyFemale[SDV.IMM.IMM] Life Sciences [q-bio]/Immunology/Immunotherapy[SDV.IMM.ALL] Life Sciences [q-bio]/Immunology/Allergology*medication scoreAdultAllergen immunotherapymedicine.medical_specialtyAdolescentDrug-Related Side Effects and Adverse ReactionsImmunologyPlacebosublingual immunotherapymedication score03 medical and health sciencesYoung AdultDouble-Blind MethodInternal medicinemedicineAnimalsHumansAntigens DermatophagoidesAsthmaHouse dust mitetabletSublingual Immunotherapyallergic rhinitisbusiness.industry[SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapymedicine.diseasebiology.organism_classificationallergyPlacebo EffectRhinitis Allergic*symptom scoresymptom scoreClinical trial030104 developmental biology030228 respiratory system*house-dust miteQuality of Lifebusinessdescription
Background: Allergic rhinitis induced by house dust mites (HDMs) is a highly prevalent but often underdiagnosed and undertreated/untreated chronic disease. It often has a negative impact on sleep, work, leisure activities, and health-related quality of life. Allergen immunotherapy is a proven, safe treatment for respiratory allergies. Objective: We sought to assess the efficacy and safety of a 300 index of reactivity (IR) sublingual tablet formulation of Dermatophagoides pteronyssinus:Dermatophagoides farinae 1:1 extract in adolescents (aged >_12) and adults with moderate to severe HDM-induced allergic rhinitis. Methods: In a phase III, international, double-blind, placebo controlled, randomized clinical trial, participants received approximately 12 months of treatment with placebo or the 300 IR tablet. The primary end point was the average total combined score during 4 weeks at the end of the treatment period. Results: A total of 1607 participants were randomized, and 1476 (including 555 [37.6%] with concomitant mild controlled asthma at inclusion) comprised the full analysis set. Over the primary evaluation period, the least squares mean average total combined score in the 300 IR group (3.62) was significantly lower (P Superscript/Subscript Available</comment
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2021-03-01 | The Journal of allergy and clinical immunology |