Evidence map›Paper›PMID 30937138›Full record

ArticleThe World Allergy Organization journal2019

Shortened up-dosing with sublingual immunotherapy drops containing tree allergens is well tolerated and elicits dose-dependent clinical effects during the first pollen season.

Ralph Mösges, Nils Y Breitrück, Silke Allekotte, Kija Shah-Hosseini, Van-Anh Dao, Petra Zieglmayer, Katrin Birkholz, Mark Hess, Maximilian Bastl, Katharina Bastl and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in The World Allergy Organization journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03097432 (A Prospective, Open, Multi-centre, Non-interventional Study to Assess the Tolerability, the Safety Profile and the Adherence of Different Up-dosing Schemes for a Sublingual Immunotherapy Treatment), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 46% 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.

NCT03097432 completednot on this map

A Prospective, Open, Multi-centre, Non-interventional Study to Assess the Tolerability, the Safety Profile and the Adherence of Different Up-dosing Schemes for a Sublingual Immunotherapy Treatment

TypeobservationalSponsorUniversity Hospital of CologneRan2016 to 2017Enrolled164ConditionsSeasonal Allergic RhinitisArmsORALVAC COMPACT BÄUME
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Coseasonal initiation of Artemisia annua sublingual immunotherapy in children and adult patients with allergic rhinoconjunctivitis.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2025
    Trial
  2. Clinical outcomes of 2-yearAsia Pacific allergy · 2026
    Article
  3. Article
  4. 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

13 authors at 4 institutions in 3 countries.

Ralph MösgesInstitute of Medical Statistics, Computational Biology (IMSB), Faculty of Medicine, University of Cologne, Cologne, Germany.
Nils Y BreitrückInstitute of Medical Statistics, Computational Biology (IMSB), Faculty of Medicine, University of Cologne, Cologne, Germany.
Silke AllekotteCRI - Clinical Research International Ltd., Cologne, Germany.
Kija Shah-HosseiniInstitute of Medical Statistics, Computational Biology (IMSB), Faculty of Medicine, University of Cologne, Cologne, Germany.
Van-Anh DaoCRI - Clinical Research International Ltd., Cologne, Germany.
Petra ZieglmayerAllergy Center Vienna West, Vienna, Austria.
Katrin BirkholzBencard Allergie GmbH, Munich, Germany.
Mark HessCRI - Clinical Research International Ltd., Cologne, Germany.
Maximilian BastlDepartment of Oto-Rhino-Laryngology, Research Group Aerobiology and Pollen Information, Medical University of Vienna, Vienna, Austria.
Katharina BastlDepartment of Oto-Rhino-Laryngology, Research Group Aerobiology and Pollen Information, Medical University of Vienna, Vienna, Austria.
Uwe BergerDepartment of Oto-Rhino-Laryngology, Research Group Aerobiology and Pollen Information, Medical University of Vienna, Vienna, Austria.
Matthias F KramerBencard Allergie GmbH, Munich, Germany.
Sonja GuethoffBencard Allergie GmbH, Munich, Germany.
Medical University of Vienna · ATUniversity of Cologne · DEAllergy Therapeutics (United Kingdom) · GBAllergiezentrum Wien West · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study compared a rapid home-based up-dosing schedule for sublingual immunotherapy (SLIT) drops containing tree pollen allergens with two previously established schedules. Furthermore, the clinical effect of the SLIT was investigated with respect to patients' first pollen season under treatment.

methodsIn this open-label, prospective, patient-preference, non-interventional study, local and systemic reactions were compared between three up-dosing groups using a SLIT formulation containing birch, alder, and hazel pollen extracts (ORALVAC

resultsIn 33 study centres in Germany and Austria, 164 patients were included. The treatment was well tolerated, without difference between the groups during the up-dosing phase. At the end of the assessment, 96.1% rated the tolerability of the treatment as good or very good. Local reactions were mostly mild in severity and no serious adverse events occurred. Symptom scores decreased from the 2016 pollen season to the 2017 pollen season. As for the ARIA classification, 79.0% of patients had persistent, moderate-to-severe rhinitis before treatment, but only 18.6% had the same classification after treatment. In all, 62.4% of patients achieved symptom control, and 34.3% of patients required no symptomatic medication after treatment. The rhinoconjunctivitis score was 34.4% lower for pre-seasonal treatment initiation than for the control group. Crowd-sourced symptom load indices showed that the 2016 season caused slightly more symptoms; however, it is assumed that this difference of 0.3-0.5 (score range 0-10) was of less clinical relevance.

conclusionThe treatment administered using the rapid home-based up-dosing schedule was safe and well tolerated. Symptom relief and reduction in medication use were observed during the first pollen season with SLIT. TRIAL REGISTRATION NUMBER: NCT03097432 (clinicaltrials.gov).

Indexed as

AdherenceAE, adverse eventARIA, Allergic Rhinitis and its Impact on AsthmaAsthmaConjunctivitisIgE, immunoglobulin EImmunotherapyN, numberPHD, Patient's Hay Fever DiaryPollen allergyPre-seasonalRCAT, Rhinitis Control Assessment TestRhinitisSD, standard deviationsIgE, specific immunoglobulin ESLI, symptom load indexSLITSLIT, sublingual immunotherapySmPC, Summary of Product CharacteristicsSublingual immunotherapyTU, therapeutic unitsV, visit

Identifiers

PMID30937138
PMCPMC6439405
OpenAlexW2921292600

What OpenQuestion holds

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Registered trials

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.