Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM (NCT05395689) | Clinical Trial Compass
RecruitingPhase 3
Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM
Spain350 participantsStarted 2022-01-17
Plain-language summary
The trial is performed to assess efficacy and safety of Beltavac with polymerized extract of house dust mites in allergic Rhinoconjunctivitis associated or not with asthma
Who can participate
Age range12 Years – 65 Years
SexALL
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Inclusion Criteria:
* Written informed consent, signed and duly dated.
* Man or woman between 12 and 65 years old (both included).
* Patient with moderate or severe symptoms of persistent rhinitis according to the ARIA Guide, associated or not with well or partially controlled asthma according to the GEMA 5.0 Guide.
* Confirmation of sensitization to DPT or DF with a positive prick test (mean papule diameter greater than or equal to 3 mm) with a commercial standardized allergenic extract and a serum extract-specific IgE value of class 3 or higher (\> 3.5 kU / L) within the 6 months prior to the study.
* Negative pregnancy test.
* Nasal symptom and medication combined scale score ≥ 1.5 during the screening phase.
Exclusion Criteria:
* Concomitant sensitization to allergens other than dust mites if clinically relevant symptoms are anticipated that may interfere with study evaluation periods at the discretion of the investigator.
* Poorly controlled asthma according to the GEMA 5.0 guideline
* Severe asthma, that is, those who during the last months have controlled their asthma according to therapeutic step 5-6 of the GEMA 5.0 guideline.
* Autoimmune diseases or immunodeficiency.
* Malignant neoplasms, serious cardiovascular disease, serious mental illness or other relevant chronic diseases that may interfere with the results of the study.
* Clinical history of anaphylaxis with cardio / respiratory symptoms.
* Hypersensitivity to any of the excipients of the investigational p…