Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM
- Conditions
- House Dust Mite Allergy
- Interventions
- Biological: PlaceboBiological: House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae
- Registration Number
- NCT05395689
- Lead Sponsor
- Probelte Pharma S.L.U.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Saline solution administered by the subcutaneous route for 12 months using a rush schedule Active substance House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae solution administered by the subcutaneous route for 12 months using a rush schedule
- Primary Outcome Measures
Name Time Method The combined nasal symptom and medication score 12 months of treatment 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.
- Secondary Outcome Measures
Name Time Method Score of the nasal symptoms scale 12 months of treatment 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.
Score of the specific medication scale 12 months of treatment. 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.
VAS score (completed by the patient and the investigator) 12 months of treatment. Visual analogue score from 0 (no symptoms) to 100mm (serious symptoms) to assess global symptoms of allergy
RCAT questionnaire 12 months of treatment. Rhinitis Control Assessment Test. Score from 6 (poor control) to 30 (good control)
Values in serum of specific IgE and IgG4 12 months of treatment. Specific IgE and IgG4 to DPT and total DF, Der p1 and Der p2, Der p23, Der f1, Der f2
ACT questionnaire 12 months of treatment Asthma Control Test Questionnaire to assess the control of asthma in asthmatic patients
Percentage of days without symptoms or medication 12 months of treatment Percentage of days with a zero value for symptom and medication recorded in the patient digital diary
Mini-RQLQ questionnaires 12 months of treatment. Mini-Rhinoconjunctivitis Quality of Life Questionnaire
Number of local and systemic reactions. 13 months of study follow up Number of local and systemic reaccions associated with the treatment
Cost-effectiveness analysis 13 months of study follow up Number days/ visits related to allergy
The combined asthma symptom and medication score 12 months of treatment 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.
PEF 12 months of treatment Peak expiratory flow measured with a Smart Peak Flow device
Trial Locations
- Locations (18)
Hospital Regional de Málaga
🇪🇸Malaga, Málaga, Spain
Hospital General de Granollers
🇪🇸Granollers, Barcelona, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Val d ' Hebron
🇪🇸Barcelona, Spain
Hospital Virgen de la Arrixaca
🇪🇸Murcia, Spain
Fundacion Sanitaria Sant Pere Claver
🇪🇸Barcelona, Spain
Hospital de Bellvitge
🇪🇸Barcelona, Spain
Hospital General de Castellón
🇪🇸Castelló, Spain
Hospital Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Germans Trias i Pujol
🇪🇸Barcelona, Spain
Hospital Universitario Infantil de la Fé
🇪🇸Valencia, Spain
Hospital de Fatima
🇪🇸Sevilla, Spain
Hospital Politecnico de la Fé
🇪🇸Valencia, Spain
Hospital de Canarias
🇪🇸Santa Cruz De Tenerife, Canarias, Spain
Hospital de la Plana
🇪🇸Castellón De La Plana, Castellón, Spain
Hospital Vega Baja
🇪🇸Orihuela, Alicante, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital infantil Vall d Hebron
🇪🇸Barcelona, Spain