Evidence map›Paper›PMID 30281866›Full record

Trial reportPediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology2019

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

Yoshitaka Okamoto, Shigeharu Fujieda, Mitsuhiro Okano, Hideaki Hida, Shinji Kakudo, Keisuke Masuyama

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
4.3field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 3 syntheses or guidelines pooled it, 66 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Allergic rhinitis activity and efficacy of 300 IR house dust mite sublingual immunotherapy tablet in pediatrics.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2026
    Trial
  5. Efficacy of house dust mite sublingual tablet in the treatment of allergic rhinoconjunctivitis: A randomized trial in a pediatric population.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2019
    Trial
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  7. Review
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  13. Allergen immunotherapy in China.Frontiers in allergy · 2023
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 1 country.

Yoshitaka OkamotoDepartment of Otorhinolaryngology-Head and Neck Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.
Shigeharu FujiedaDepartment of Otorhinolaryngology-Head and Neck Surgery, University of Fukui, Fukui, Japan.
Mitsuhiro OkanoDepartment of Otorhinolaryngology, School of Medicine, International University of Health and Welfare, Narita, Japan.
Hideaki HidaBiostatistics Center, Shionogi & Co., Ltd., Osaka, Japan.
Shinji KakudoProject Management Department, Shionogi & Co., Ltd., Osaka, Japan.ORCID 0000-0003-4050-5153
Keisuke MasuyamaDepartment of Otorhinolaryngology-Head and Neck Surgery, Graduate School of Medical Science, University of Yamanashi, Yamanashi, Japan.
Shionogi (Japan) · JPChiba University · JPInternational University of Health and Welfare · JPUniversity of Fukui · JPUniversity of Yamanashi · JP

Funding

Shionogi & Co., Ltd.
6 · The paper itself

Abstract

backgroundThe 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).

methodsPatients 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).

resultsOf 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 < 0.0001). Almost all patients experienced mild or moderate adverse events (AEs). The most common treatment-related AEs were oral pruritus, mouth edema, throat irritation, and ear pruritus. One patient experienced serious pseudocroup (subglottic laryngitis) that recovered. There were no deaths or anaphylaxis requiring the use of injectable adrenaline.

conclusionsThe HDM tablet significantly improved symptoms of HDM-induced perennial AR and was associated with a significant immunological response. The safety profile in pediatric patients was consistent with that in adults, with no new safety concerns.

Indexed as

AdolescentAllergensAnimalsAntigens, DermatophagoidesChildChild, PreschoolDouble-Blind MethodFemaleHumansJapanMalePyroglyphidaeRhinitis, AllergicSublingual ImmunotherapyTreatment OutcomeAllergensAntigens, Dermatophagoidesallergens: inhalative allergensrhinitis: allergicrhinitis: clinical trialsrhinitis: specific immunotherapySIT: SLIT

Identifiers

PMID30281866
PMCPMC7379546
OpenAlexW2894559667

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.