Evidence map›Paper›PMID 27068870›Full record

Trial reportAllergy2017

A 12-week DBPC dose-finding study with sublingual monomeric allergoid tablets in house dust mite-allergic patients.

C Hüser, P Dieterich, J Singh, K Shah-Hosseini, S Allekotte, W Lehmacher, E Compalati, R Mösges

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Allergy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Guideline on allergen immunotherapy in IgE-mediated allergic diseases: S2K Guideline of the German Society of Allergology and Clinical Immunology (DGAKI), Society of Pediatric Allergology and Environmental Medicine (GPA), Medical Association of German Allergologists (AeDA), Austrian Society of Allergology and Immunology (ÖGAI), Swiss Society for Allergology and Immunology (SSAI), German Dermatological Society (DDG), German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), German Society of Pediatrics and Adolescent Medicine (DGKJ), Society of Pediatric Pulmonology (GPP), German Respiratory Society (DGP), German Professional Association of Otolaryngologists (BVHNO), German Association of Paediatric and Adolescent Care Specialists (BVKJ), Federal Association of Pneumologists, Sleep and Respiratory Physicians (BdP), Professional Association of German Dermatologists (BVDD).Allergologie select · 2022
    Article
  7. EAACI Allergen Immunotherapy User's Guide.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2020
    Review
  8. Review
  9. Modified Allergens for Immunotherapy.Current allergy and asthma reports · 2018
    Review
  10. Review
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

8 authors.

C HüserInstitute for Medical Statistics, Informatics and Epidemiology, Faculty of Medicine, University of Cologne, Cologne, Germany.
P DieterichInstitute for Medical Statistics, Informatics and Epidemiology, Faculty of Medicine, University of Cologne, Cologne, Germany.
J SinghInstitute for Medical Statistics, Informatics and Epidemiology, Faculty of Medicine, University of Cologne, Cologne, Germany.
K Shah-HosseiniInstitute for Medical Statistics, Informatics and Epidemiology, Faculty of Medicine, University of Cologne, Cologne, Germany.
S AllekotteInstitute for Medical Statistics, Informatics and Epidemiology, Faculty of Medicine, University of Cologne, Cologne, Germany.
W LehmacherInstitute for Medical Statistics, Informatics and Epidemiology, Faculty of Medicine, University of Cologne, Cologne, Germany.
E CompalatiMedical Department, Lofarma S.p.A., Milan, Italy.
R MösgesInstitute for Medical Statistics, Informatics and Epidemiology, Faculty of Medicine, University of Cologne, Cologne, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn sublingual immunotherapy, optimal doses are a key factor for therapeutic outcomes. The aim of this study with tablets containing carbamylated monomeric house dust mite allergoids was to determine the most effective and safe dose.

methodsIn this double-blind, placebo-controlled dose-finding study, 131 patients with house dust mite-induced allergic rhinoconjunctivitis were randomized to 12-week treatments with 300 UA/day, 1000 UA/day, 2000 UA/day, 3000 UA/day or placebo. Conjunctival provocation tests (CPT) were performed before, during and after treatment. The change in mean allergic severity (primary endpoint), calculated from the severity of the CPT reaction, and the proportion of patients with an improved CPT threshold (secondary endpoint) determined the treatment effect.

resultsThe mean allergic severity decreased in all groups, including the placebo group. It was lower in all active treatment groups (300 UA/day: 0.14, 1000 UA/day: 0.15, 2000 UA/day: 0.10, 3000 UA/day: 0.15) than in the placebo group (0.30). However, this difference was not statistically significant (P < 0.1). The percentage of patients with an improved CPT threshold was higher in the active treatment groups (300 UA/day: 73.9%; 1000 UA/day: 76.0%; 2000 UA/day: 88.5%; 3000 UA/day: 76.0%) than in the placebo group (64.3%). The difference between placebo and 2000 UA/day was statistically significant (P = 0.04). In 13 (10%) exposed patients, a total of 20 treatment-related adverse events of mild severity were observed.

conclusionsThe 12-week daily treatment using 2000 UA/day monomeric allergoid sublingual tablets is well tolerated and reduces the CPT reaction in house dust mite-allergic patients.

Indexed as

Sublingual ImmunotherapyAllergensAllergoidsAnimalsFemaleHumansHypersensitivityMalePlant ExtractsPyroglyphidaeTime FactorsTreatment OutcomeAllergensAllergoidsPlant Extractsallergic rhinoconjunctivitiscarbamylated monomeric allergoid tabletsdose-finding studyhouse dust mitessublingual immunotherapy

Identifiers

PMID27068870
PMCPMC5217067

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.