Efficacy of house dust mite sublingual tablet in the treatment of allergic rhinoconjunctivitis: A randomized trial in a pediatric population

Autor: Shigeharu Fujieda, Hideaki Hida, Mitsuhiro Okano, Keisuke Masuyama, Yoshitaka Okamoto, Shinji Kakudo
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Male
medicine.medical_specialty
Adolescent
Airways Disease
Immunology
Nasal congestion
Placebo
law.invention
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
Double-Blind Method
Japan
law
Internal medicine
medicine
Immunology and Allergy
Animals
Humans
Antigens
Dermatophagoides
030223 otorhinolaryngology
Adverse effect
Child
allergens: inhalative allergens
House dust mite
Throat irritation
rhinitis: allergic
Sublingual Immunotherapy
rhinorrhea
biology
business.industry
Pyroglyphidae
Repeated measures design
Allergens
biology.organism_classification
Rhinitis
Allergic
rhinitis: specific immunotherapy
rhinitis: clinical trials
Treatment Outcome
030228 respiratory system
Child
Preschool
Pediatrics
Perinatology and Child Health
SIT: SLIT
Original Article
Female
medicine.symptom
ORIGINAL ARTICLES
business
Zdroj: Pediatric Allergy and Immunology
ISSN: 1399-3038
0905-6157
Popis: Background The efficacy and safety of 300 index of reactivity (IR) tablets of house dust mite (HDM) allergen extracts in Japanese pediatric (5‐16 years old) patients with allergic rhinitis (AR) were assessed in a double‐blind, randomized, placebo‐controlled study (JAPIC CTI‐152981). Methods Patients were randomized 1:1 to HDM sublingual tablets or placebo once daily for 52 weeks. The primary end‐point was average adjusted symptom score (AASS; average of daily Rhinitis Total Symptom Scores, comprising sneezing, rhinorrhea, nasal congestion, and nasal pruritus, adjusted for rescue medication use), analyzed during Weeks 48‐52 (mixed‐effects model for repeated measures). Results Of 438 patients randomized, 403 (92%; 193 active, 210 placebo) completed the study. AASS (least‐squares [LS] mean [SE]) during Weeks 48‐52 was significantly (P = 0.0005) lower in the active group compared with placebo (6.32 [0.20] vs 7.27 [0.19]; relative LS mean difference, −13%). Immunological responses (IgE and IgG4 antibodies specific to antigens of two HDM species) were significantly greater in the active group compared with placebo (P
Databáze: OpenAIRE
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