| Autor: |
Antje Schuster, Davide Caimmi, Hendrik Nolte, Silviya Novakova, Jan Mikler, Majken Hougaard Foss-Skiftesvik, Anne Sofie Østerdal, Andrzej Emeryk, Remi Gagnon, Oliver Pfaar |
| Jazyk: |
angličtina |
| Rok vydání: |
2025 |
| Předmět: |
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| Zdroj: |
The Lancet Regional Health. Europe, Vol 48, Iss , Pp 101136- (2025) |
| Druh dokumentu: |
article |
| ISSN: |
2666-7762 |
| DOI: |
10.1016/j.lanepe.2024.101136 |
| Popis: |
Summary: Background: Allergic rhinitis/rhinoconjunctivitis (AR/C) induced by house dust mites (HDM) often begins in childhood and negatively impacts a child’s quality of life. The daily burden can be further compounded by comorbid asthma. Allergen immunotherapy is the only available treatment targeting the underlying cause of allergic disease. Efficacy and safety of the SQ HDM sublingual immunotherapy (SLIT)-tablet has been demonstrated in adults and adolescents with HDM AR/C with or without asthma, but data are lacking for younger children. Methods: Phase III, randomised, double-blind, placebo-controlled trial in younger children (5–11 years) with HDM AR/C with or without asthma. Eligible subjects were randomised 1:1 to SQ HDM SLIT-tablet or placebo for ∼1 year and had free access to AR/C symptom-relieving medications. The primary outcome was the total combined rhinitis score (TCRS) during the final 8 weeks of the treatment period (∼1 year). Secondary outcomes included the rhinitis daily symptom score (DSS) and medication score (DMS), the rhinoconjunctivitis total combined score (TCS), and the Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) score. Efficacy analyses were conducted on the full analysis set (observed cases). Asthma-related outcomes were also explored. The trial was registered on ClinicalTrials.gov: NCT04145219 and EudraCT: 2019-000560-22. Findings: A total of 1460 subjects were randomised to SQ HDM SLIT-tablet (n = 729) or placebo (n = 731). The primary outcome, TCRS, was statistically significantly different for SQ HDM SLIT-tablet (n = 693) versus placebo (n = 706), with an absolute difference of 1.0 (95% CI: 0.5, 1.4; p |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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