Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM

Study Overview
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Brief Summary
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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

Official Title
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Efficacy and Safety Assessment of a Subcutaneous Immunotherapy (Beltavac®) With Polymerized Allergenic Extract From House Dust Mites in Patients With Allergic Rhinitis/Rhinoconjuntivitis

Conditions
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House Dust Mite Allergy

Intervention / Treatment
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* Biological: House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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 product. Immunosuppressive medication during the last 6 months before the inclusion of patients and until the end of the study. Treatment with beta-blockers during the study. Patients who have previously received immunotherapy with allergenic dust mite extract or other extracts and have failed within the last 5 years. Patients with immunotherapy with allergens other than dust mites during the study period. Patients who receive any other vaccine one week before the start of treatment or awaiting the second dose of vaccine against COVID-19. Pregnant or nursing patients.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active substance<br>House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae solution administered by the subcutaneous route for 12 months using a rush schedule | Biological: House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae<br>* The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year<br>|
| Placebo Comparator: Placebo<br>Saline solution administered by the subcutaneous route for 12 months using a rush schedule | Biological: Placebo<br>* The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The combined nasal symptom and medication score | The symptoms assessed are: itchy nose, sneezing, runny nose, and blocked nose (all rated from 0-3). The medication score is 1 for oral and/or topical antihistamines, 2 for intranasal corticosteroids, and 3 for oral corticosteroids. The scores from the nasal symptoms are added and divided by 4 to a total daily symptom score from 0-3.Final score range from 0 to 6, higher score meaning a worse outcome. | 12 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of the nasal symptoms scale | Symptoms assessed are: itchy nose, sneezing, runny nose, and blocked nose (all rated from 0-3). Final score range from 0 to 3, higher score meaning worse outcome. | 12 months of treatment | 
| Score of the specific medication scale | The medication score is 1 for oral and/or topical antihistamines, 2 for intranasal corticosteroids, and 3 for oral corticosteroids. Final score range from 0 to 3, higher score meaning worse outcome. | 12 months of treatment. | 
| Percentage of days without symptoms or medication | Percentage of days with a zero value for symptom and medication recorded in the patient digital diary | 12 months of treatment | 
| VAS score (completed by the patient and the investigator) | Visual analogue score from 0 (no symptoms) to 100mm (serious symptoms) to assess global symptoms of allergy | 12 months of treatment. | 
| RCAT questionnaire | Rhinitis Control Assessment Test. Score from 6 (poor control) to 30 (good control) | 12 months of treatment. | 
| Mini-RQLQ questionnaires | Mini-Rhinoconjunctivitis Quality of Life Questionnaire | 12 months of treatment. | 
| Values in serum of specific IgE and IgG4 | Specific IgE and IgG4 to DPT and total DF, Der p1 and Der p2, Der p23, Der f1, Der f2 | 12 months of treatment. | 
| Number of local and systemic reactions. | Number of local and systemic reaccions associated with the treatment | 13 months of study follow up | 
| Cost-effectiveness analysis | Number days/ visits related to allergy | 13 months of study follow up | 
| The combined asthma symptom and medication score | The symptoms assessed are: symptoms during the day, symptoms during the night and physical activity limitations (all rated from 0-3). The medication score is 1 for inhalated corticoids (low dose) , 2 for inhalated corticosteroids associated with LABA, and 3 for inhalated corticosteroids medium dosis associated with LABA. The scores from the symptoms are added and divided by 3 to a total daily symptom score from 0-3. The total daily medication score ranges from 0-3. | 12 months of treatment | 
| PEF | Peak expiratory flow measured with a Smart Peak Flow device | 12 months of treatment | 
| ACT questionnaire | Asthma Control Test Questionnaire to assess the control of asthma in asthmatic patients | 12 months of treatment |