Evidence map›Paper›PMID 39698951›Full record

Trial reportImmunity, inflammation and disease2024

Clinical Trial With a Depigmented, Polymerized Mite Mixture Extract at Maximum Concentrations.

Carmen Vidal, Laura Romero, Sara Lopez-Freire, Francisco Carballada-Gonzalez, José Carlos Garcia-Robaina, Teresa Gonzalez-Fernandez, Paula Mendez-Brea, Eva Nieto, Mónica Ruiz-Garcia

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Immunity, inflammation and disease, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. Article
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

9 authors.

Carmen VidalComplejo Hospitalario de Santiago, Santiago de Compostela, Spain.
Laura RomeroComplejo Hospitalario de Santiago, Santiago de Compostela, Spain.
Sara Lopez-FreireComplejo Hospitalario de Santiago, Santiago de Compostela, Spain.
Francisco Carballada-GonzalezHospital Lucus Augusti, Lugo, Spain.
José Carlos Garcia-RobainaHospital Universitario de La Candelaria, Santa Cruz de Tenerife, Spain.
Teresa Gonzalez-FernandezHospital Lucus Augusti, Lugo, Spain.
Paula Mendez-BreaComplejo Hospitalario de Santiago, Santiago de Compostela, Spain.
Eva NietoMedical Affairs and Clinical Department, LETI Pharma S.L.U., Madrid, Spain.
Mónica Ruiz-GarciaMedical Affairs and Clinical Department, LETI Pharma S.L.U., Madrid, Spain.ORCID 0000-0001-8006-6453

Funding

LETI Pharma sponsored this study.
6 · The paper itself

Abstract

backgroundEfficacy of allergen immunotherapy is dose-dependent; however, high doses of allergen may imply a greater risk of adverse reactions.

objectiveTo assess the safety and tolerability of subcutaneous immunotherapy (SCIT) with mixtures of mite allergen extracts, Dermatophagoides pteronyssinus/Blomia tropicalis (Dpt/Bt) and Dermatophagoides pteronyssinus/Lepidoglyphus destructor (Dpt/Ld) at maximum concentrations, in adult patients with allergic rhinitis or rhinoconjunctivitis, and controlled allergic asthma due to a clinically relevant sensitisation to these mites.

methodsAn open-label, noncontrolled, nonrandomised, phase IIb clinical trial was carried out in three hospitals in Spain between September 2014 and May 2018. Patients received SCIT of either Dpt/Bt (100/1000 DPP/mL) or Dpt/Ld (100/100 DPP/mL) in two phases: a rush build-up phase on the first day (0.2 mL and 0.3 mL with a 30-min interval) and a monthly maintenance phase administration (0.5 mL) up to 48 months.

resultsForty patients were recruited for the study, seven allocated to the Dpt/Bt group and 33 to the Dpt/Ld. None experienced immediate or delayed systemic Grade ≥ 2 reactions (EAACI classification) (systemic reactions were mostly Grade 1) nor died during the study. Local reactions were mostly mild (0‒10 cm). Thirty-nine patients (97.5%) experienced at least one adverse event (AE). Of the 283 reported AEs, eight (2.8%) were systemic reactions experienced by six (15%) subjects and 14 (4.9%) were local reactions sustained by ten (25%) subjects.

conclusionsSCIT treatment of patients with allergic rhinitis or rhinoconjunctivitis and controlled asthma with mixtures of Dpt/Bt and Dpt/Ld allergen extracts at maximum concentrations showed a favourable safety profile.

Indexed as

Antigens, DermatophagoidesDesensitization, ImmunologicAdolescentAdultAgedAllergensAnimalsAsthmaConjunctivitis, AllergicDermatophagoides pteronyssinusFemaleHumansMaleMiddle AgedRhinitis, AllergicTreatment OutcomeAllergensAntigens, Dermatophagoidesallergic asthmaallergic rhinitisblomia tropicalisdermatophagoides pteronyssinushouse dust miteslepidoglyphus destructormaximum extract concentrations safety

Identifiers

PMID39698951
PMCPMC11656404

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Registered trials

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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.